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High Voltage (HV) Splitter/Adaptor 5019

Databases MEDLINE
Searched EMBASE
Specified 01 Jan 2006 – 31 Jan 2016
Timeframe

Search #2 – Lead Accessories Industry-wide Literature

A second search was conducted for the lead accessory terms combined with the therapy terms as
outlined in the table below. All patents, guidelines, notes, editorials and letters were removed. The
search was limited to English language, human only papers from 01 Nov 2010 to 31 Jan 2016. A total of
21 unique articles were located.
Search Terms Lead Accessory Terms: stylet OR lead introducer OR rotation tool OR medical
adhesive OR lead splice kit OR wrench kit OR pin plug kit OR lead end cap OR
lead accessory kit OR lead repair kit OR lead tool kit OR adaptor kit OR lead
extender OR splitter OR adaptor

COMBINED WITH

Therapy Terms: ICD OR pacemaker OR CRT OR cardiac resynchronization

therapy OR implantable cardioverter defibrillator OR lead OR leads OR electrode
OR biventricular pacing OR biventricular pacemaker

LIMITED TO

Study Types: clinical trials OR meta analyses OR registries

Databases MEDLINE
Searched EMBASE
Specified 01 Nov 2010 – 31 Jan 2016
Timeframe

Final Result
Results from Search #1 and Search #2 were combined and duplicates were removed. A total of 25
unique articles were located. Abstracts for these articles appear below, if available.

1.1 Unedited search results

Table 5: Unedited search results

Set Number of
Search Terms
Number Articles
L1 1 (MEDTRONIC OR STYLET?) AND (6093 OR 6048 OR 6052 OR 6054 OR 6057 OR
6082 OR 6091 OR 6094 OR 6254 OR 6282 OR 6293)
L2 0 (MEDTRONIC OR LEAD(W) ACCESSORY OR ACCESSORY(W)KIT?) AND 6056M
L3 1 (MEDTRONIC OR ROTATIONAL(W) TOOL(W) KIT?) AND 6056
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Set Number of
Search Terms
Number Articles
L4 25,358 (MEDTRONIC OR PIN(W) PLUG(W) KIT? OR MEDICAL(W) ADHESIVE OR
ANCHORING(W) SLEEVE? OR LEAD(W) END(W) CAP OR LEAD(W)SPLICE(W)
KIT! OR WRENCH(W) KIT! OR LEAD(W) EXTENDER? OR SPLITTER(W)
ADAPTOR?)
L5 241 (6725 OR 080118 OR 5867(W) 2 OR 5867(W) 3M OR 5867(W) 5 OR 5873C OR 5873W
OR 5019 OR 6981M OR 6984M OR 6985M OR 6986M)
L6 2 L4 AND L5
L7 25,307 (MEDTRONIC OR VITATRON OR SOLOTRAK OR LEAD(W) INTRODUCER?)
L8 599 (6207BTK(W) 1 OR 6207BTK(W) 5 OR 6207BTK(W) D1 OR 6207BTKL(W) 1 OR
6207(W) D1 OR 6207(W) S1 OR 6207(W) S5 OR 6208BTK(W) 1 OR 6208BTK(W) 5
OR 6208BTK(W) D1 OR 6208BTKL(W) 1 OR 6208(W)D1 OR 6208(W) S1 OR 6208(W)
S5 OR 6209BTK(W) 1 OR 6209?)
L9 0 (6210BTK(W) 1 OR 6210BTK(W) 5 OR 6210BTK(W) D1 OR 6210BTKL(W) 1 OR
6210(W) D1 OR 6210(W) S1 OR 6210(W) S5 OR 6211BTK(W) 1 OR 6211BTK(W) 5
OR 6211BTK(W) D1 OR 6211(W) D1 OR 6211(W) S1 OR 6211(W) S5 OR
6212BTK(W) 1 OR 6212BTK(W) 5 OR 6212(W) S1 OR 6212(W) S5 OR 6214BTK(W) 1
OR 6214BTK(W) 5 OR 6214(W) S1 OR 6214(W) S5)
L11 0 (VIK(W) 10D1 OR VIK(W) 10S1 OR VIK(W) 10S5 OR VIK(W) 11D1 OR VIK(W) 11S1
OR VIK(W) 11S5 OR VIK(W) 12D1 OR VIK(W) 12S1 OR VIK(W) 12S5 OR VIK(W)
7D1 OR VIK(W) 7S1 OR VIK(W) 7S5 OR VIK(W) 8D1 OR VIK(W) 8S1 OR VIK(W)
8S5 OR VIK(W) 9D1 OR VIK(W) 9S1 OR VIK(W) 9S5)
L12 0 L7 AND ((L8 OR L9 OR L10))
L13 2 (MEDTRONIC OR VITATRON) AND (SOLOTRAK OR LEAD(W) INTRODUCER?)
L14 7 (MEDTRONIC OR ADAPTOR(W) KIT?) AND (5866(W) 23 OR 5866(W) 24(W) M OR
5866(W) 38M OR 5866(W) 40M OR 5866(W) 45 OR 5866(W) 46 OR 2872)
L15 13 L1 OR L3 OR L6 OR L12 OR L13
L16 8 L14 AND PD=20060101-20160131
L17 5 L15 NOT ((COMMENTARY OR CONFERENCE? OR CONGRESS? OR EDITORIAL
OR GUIDELINE? OR LETTER OR PRACTICE GUIDELINE OR NOTE)/DT OR
(PATENT# OR (OFFICIAL(W) GAZETTE))/SO)
L18 5 L16/HUMAN,ENG
L19 4 DUP REM L17 (1 DUPLICATE REMOVED)
L20 9,804 (STYLET OR LEAD(W) INTRODUCER? OR ROTATION(W) TOOL! OR
MEDICAL(W) ADHESIVE! OR LEAD(W) SPLICE(W) KIT! OR WRENCH(W)KIT!
OR PIN(W) PLUG(W) KIT! OR LEAD(W) END(W) CAP OR
LEAD(W)ACCESSORY(W) KIT! OR LEAD(W) REPAIR(W) KIT! OR LEAD(W)
TOOL(W)KIT! OR ADAPTOR(W) KIT! OR LEAD(W) EXTENDER! OR SPLITTER!
OR ADAPTOR!)
L21 2,033,540 (ICD OR PACEMAKER? OR CRT OR CARDIAC(W) RESYNCH? OR
IMPLANTABLE(2A) DEFIBRILLATOR? OR LEAD OR LEADS OR ELECTRODE!
OR BIVENTRICULAR)
L22 893 L19 AND L20
L23 405 L21 AND PD=20101101-20160131
L24 2,438,849 (CLINICAL TRIAL OR COMPARATIVE STUDY OR CONTROLLED CLINICAL
TRIAL OR EVALUATION STUDY OR META ANALYSIS OR MULTICENTER
STUDY OR RANDOMIZED CONTROLLED TRIAL OR TECHNICAL REPORT OR
VALIDATION STUDIES OR COCHRANE DATABASE)/DT
L25 4,890,992 (CLINICAL(W) TRIAL# OR MULTICENTER(W) STUD? OR META(W) ANALYS!S
OR RANDOMI!ED(2A) TRIAL# OR DOUBLE(W) BLIND? OR SINGLE(W) BLIND?
OR SYSTEMATIC(W) REVIEW# OR SINGLE(W) CENTER OR CLINICAL(W)
STUDY OR CLINICAL(W) STUDIES OR TECHNOLOGY(W)ASSESSMENT)
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Set Number of
Search Terms
Number Articles
L26 2,865,280 (CASE(W) CONTROL(W) STUD? OR PROSPECTIVE(W) STUD? OR
COMPARATIVE(W) STUD? OR REGISTRY OR REGISTRIES OR
OBSERVATIONAL(W) STUD? OR LONGITUDINAL(W) STUD? OR PRACTICE(W)
GUIDELINE?)
L27 50 L22 AND ((L23 OR L24 OR L25))
L28 35 L26 NOT ((COMMENTARY OR CONFERENCE? OR CONGRESS? OR EDITORIAL
OR GUIDELINE? OR LETTER OR PRACTICE GUIDELINE OR NOTE)/DT OR
(PATENT# OR (OFFICIAL(W) GAZETTE))/SO)
L29 33 L27/HUMAN,ENG
L30 21 DUP REM L28 (12 DUPLICATES REMOVED)
L31 25 L30 OR L19
L32 25 DUP REM L31 (0 DUPLICATES REMOVED)
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2 Appendix C – Literature selection process

The literature search and selection process described below was conducted to include all scientific
literature, both favorable and unfavorable.
The objective of the search was to assess clinical evidence for the safety and performance of the general
lead accessories and to ensure that the devices meet their intended use in current clinical practice. In
order to meet this objective, two separate searches were conducted to obtain articles published within the
reporting period of 01 Jan 2006 to 31 Jan 2016. The searches focused on human studies addressing use
of the general lead accessories. The first search focused on the specific Medtronic and Vitatron models.
The second search focused on industry-wide use of general lead accessories.
The searches were limited to English language, human only, clinical studies, randomized controlled
trials, case series or meta-analyses. All editorials, notes, comments, letters, books, conference papers,
practice guidelines and patents were removed from the search results.
The first literature search yielded a total of 4 unique articles and the second search yielded a total of 21
unique articles. The searches were combined and duplicates were removed. A total of 25 unique articles
were located in the database literature search and an additional 8 articles were retrieved through hand-
search of the previous CER. Collectively, a total of 33 articles were identified.
The following criteria were used to appraise the relevance and the quality or limitations of the scientific
literature.
 Relevance:
o Highly relevant
 Data were generated from the actual device.
 The device used was for the same intended use.
 The data were generated from an applicable patient group that is representative of the
intended treatment population and clinical condition.
 The data are sufficient to be able to undertake a rational and objective assessment
(high quality). (This includes: randomized controlled trials, prospective controlled
trials, rigorous study design large trials, meta analysis.)
o Relevant
 Data were generated from the actual device.
 The device used was for the same intended use.
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 The data were generated from an applicable patient group that is representative of the
intended treatment population and clinical condition.
 The data are sufficient to be able to undertake a rational and objective assessment, but
may contain minor deficiencies or insufficient information. (This includes: Non-
randomized trials, case series or case studies ≥ 10 patients, case-controlled and cohort
studies < 50 patients, retrospective studies, registries).
o Related
 Data does not fit the criteria above but still relates to the device safety and/or
performance.
o Not Relevant
 All literature such as study design articles, position articles, review articles with no
original results, conference abstracts and articles reporting on studies with endpoints
not related to the lead accessories included in this evaluation. Publications classified
as not relevant are not included in the appraisal in Table 6.

 Quality/Limitations:
o Appropriate study design.
o The outcome measures reported reflect the intended performance of the device.
o Duration of follow-up is sufficient to assess the treatment effects and identify complications.
o Statistical analysis of the data been provided and is it appropriate.
o The magnitude of the treatment effect observed was clinically significant.
Of the 33 total articles identified, 14 articles were included in the clinical evaluation; 0 articles were
classified as highly relevant, 1 article was classified as relevant, 13 articles were classified as related,
and 19 articles were classified as not relevant based on the criteria listed above. The full text articles
classified as relevant or related were then reviewed in detail. The results reported in the relevant and
related articles have been included in the clinical analysis in Sections 6.1 and 6.2. The detailed appraisal
of all relevant articles is included in Appendix D. Figure 1 summarizes the results of the selection
process.
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Potentially relevant studies identified

through the search of EMBASE and
MEDLINE
N = 25
Studies excluded
N=19
 Non-cardiac studies (n = 8)
 Studies did not include or
focus on general lead
accessories (n = 11)
Studies retrieved for more detailed
assessment
N=6

Studies retrieved through

hand-search of the Studies excluded, classified
previous CER as not relevant
N=8 N=0

Studies with useable data included in

the appraisal table, by outcome
N = 14
 Performance (n = 14)
 Safety (n = 9)
 Actual device (n = 1)

Figure 1: Literature Selection Process Diagram

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3 Appendix D – Literature appraisal

Table 6 includes the appraisal of the literature deemed highly relevant and relevant to the safety and
performance of the lead accessories listed in Table 1.
Table 6: Literature appraisal table
5
Acosta H, Pothula Vijayasimha R, Rodriguez M, Ramadas S, Castellanos A. Placement of a pacing lead at
Full
the inferior portion of the interatrial septum without special tools. Pacing and clinical electrophysiology -
Citation
PACE. 2007;30 Suppl 1:S84-87.
Objective: The authors describe a relatively straightforward technique to insert a lead at this site without
special tools. A technique using the "preshaped" stylet and fluoroscopic guidance is described.
Device: A straight stylet was preshaped in a modified J-form, with 3–4 cm distance between the tip of the
stylet and its main axis.
Study Indication: ACC/AHA class I and II pacing indications and histories of paroxysmal or permanent atrial
summary fibrillation undergoing implantation of a dual chamber pacing system.
Type of study: Observational
N: 117 consecutive patients
Follow-up: Acute
Performance results: The intrinsic P-wave duration was 117 ± 22 ms, and the paced P-wave duration was 90
± 20 ms (23% shortening, P < 0.001). The mean time required to insert the atrial lead was 12 ± 8 minutes.
Results
Safety results: The insertion was successful in 111 patients (95%). Acute dislodgement occurred in six
patients (5%). No complications occurred.
Relevance: Related; The manufacturer of the stylets was not specified. The leads were manufactured by St.
Jude and Medtronic.
Limitations: 1) A straight stylet was preshaped in a modified J-form so the results are limited in that they
Critical
cannot be directly compared to the safety and/or performance of unaltered straight or J-shaped stylets. 2) The
Evaluation
manufacturer of the accessories was not specified.
Conclusion: Insertion of an active fixation lead at the inferior portion of the interatrial septum was safe and
highly successful in the majority of patients with this technique.
6
Full Bracke FA, Dekker L, Van Gelder BM. The Needle's Eye Snare as a primary tool for pacing lead
Citation extraction. Europace. 2013;15(7):1007-1012.
Objective: To describe a single-centre experience with a Femoral Introducer Sheath and Needle’s Eye Snare
as a primary tool for extraction of pacing leads in consecutive procedures.
Device: Standard stylets and Needle’s Eye Snare (Cook Medical Inc.)
Study Indication: Patients were indicated for extraction of atrial, right ventricular (RV), and coronary sinus (CS)
summary pacing leads
Type of study: Prospective
N: 476 leads in 229 patients
Follow-up: Acute
Performance results: First, traction was performed with a standard stylet, and if unsuccessful this was
followed by the femoral approach with a Needle’s Eye Snare. Traction sufficed for 136 (28.5%) leads and a
Results femoral approach was required in 340 (71.5%) leads, their respective implant times were 3.7±2.9 and 9.2±5.8
years.
Safety results: Major complications occurred in two patients (0.7%): both perforations of the atrial wall after
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successful extracting the lead with a Needle’s Eye Snare. Both patients were immediately operated on and
recovered completely. There were no other procedural cardiovascular complications.
Relevance: Related; The manufacturer of the stylets was not specified.
Limitations: 1) The manufacturer of the stylets was not specified. 2) Duration of the extraction and
fluoroscopy times were not systematically recorded.
Critical
Evaluation Conclusion: Needle’s Eye Snare lead extraction has a low complication rate. The technique should be
considered as a primary tool for extraction of pacing leads, particularly atrial and coronary sinus pacing leads.
The results for extracting ventricular leads might be improved if larger bore sheaths with a better cutting edge
were available.
7
Full Burri H, Domenichini G, Sunthorn H, Ganiere V, Stettler C. Comparison of tools and techniques for
Citation implanting pacemaker leads on the ventricular mid-septum. Europace. 2012;14(6):847-852.
Objective: To compare two stylet shapes to achieve mid-septal lead placement, as well as the utility of a novel
right anterior oblique (RAO) fluoroscopic landmark.
Device: A standard stylet was manually shaped into a smooth large curve in a single plane over the distal 20
cm using the barrel of a 10 cc syringe [two-dimensional (2D) stylet]. This stylet shape has been used by the
operator for septal lead placement since ~10 years. For the stylet with an additional posterior curve [three-
dimensional (3D) stylet], a 90° curve was first shaped over the distal 3 cm using the stiffest stylet in the set and
Study the barrel of a 2 cc syringe. The stylet knob was then rotated counterclockwise 90°, and a second large 180°
summary curve shaped in the same manner as the 2D stylet. The 3D stylet was more recently adopted by the operator for
septal lead placement (with an experience of ~30 patients before starting the study).
Indication: Pacemaker implantation for a standard indication
Type of study: Prospective
N: 113 patients
Follow-up: 1-2 months
Performance results: Septal position was achieved in only 10 of 22 (45%) patients in the 2D stylet group and
in 17 of 23 (74%) patients in the 3D stylet group (P = 0.07) when only postero-anterior (PA) and left anterior
oblique (LAO) fluoroscopy were used. Results were significantly improved by additional use of RAO
fluoroscopy, with successful septal placement in 25 of 28 (89%) patients in the 2D stylet + RAO group (P =
0.001) and 32 of 33 (97%) patients in the 3D stylet + RAO group (P = 0.015).
Results
Safety results: There were five lead dislodgments that all occurred within 24 h of implantation. Of these, one
(2%) involved use of a 2D stylet (with a Medtronic 5076 lead) and four (7%) involved use of a 3D stylet with
one St Jude Medical 1888T lead and three Medtronic 5076 leads. There were no lead dislodgments in the last
25 patients implanted with a 3D stylet. All leads were successfully repositioned, and there were no other
perioperative complications.
Relevance: Related; The manufacturer of the stylets was not specified.
Limitations: 1) A straight stylet was preshaped in a modified J-form so the results are limited in that they
cannot be directly compared to the safety and/or performance of unaltered straight or J-shaped stylets. 2)
Additionally, the study was not randomized and it was conducted by a single operator. 3) The manufacturer of
the accessories was not specified.
Critical
Evaluation Conclusion: The technique described in this study allows a high success rate of mid-septal lead positioning.
This may avoid ventricular perforation that may complicate inadvertent anterior placement. Our current
strategy for septal lead implantation is to attempt lead positioning using the 2D stylet with the RAO
fluoroscopic landmark. This avoids an extra stylet exchange and may confer a more stable lead position. In
case the target position is not achieved within a few attempts, a 3D stylet may be used to facilitate
implantation.
8
Cecchin F, Atallah J, Walsh Edward P, Triedman John K, Alexander Mark E, Berul Charles I. Lead
Full
extraction in pediatric and congenital heart disease patients. Circulation. Arrhythmia and
Citation
electrophysiology. 2010;3(5):437-444.
Study Objective: To report experience from a single-center cohort study with a retrospective review of prospectively
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summary collected data on all lead extractions performed between January 2002 and December 2008.
Device: Nonlocking stylets, anchoring sleeves, locking stylets (LIBERATOR Locking Stylet, Cook Vascular),
stainless steel sheath (Byrd Telescoping Stainless Stell Dilator Sheath Set, Cook), RF-powered sheath
(PERFECTA, electrosurgical Disscation Sheath, Cook), nonpowered polypropylene sheath (Byrd Dilator
Sheath Set, Polypropylene, Cook), snare (Byrd Workstation femoral intravascular retrieval set, Cook)
Indication: All patients having undergone pacemaker or ICD implantation and a lead extraction performed
>30 days after lead implant.
Type of study: Prospective, cohort study
N:144 patients and 203 leads
Follow-up: Acute
Performance results: 61 patients (42%) were female and 86 (60%) had structural heart disease. Successful
simple extraction, requiring the use of only a nonlocking stylet, was achieved in 59 (29%) leads. Of the
remaining leads, 35 were abandoned and 109 underwent complex extraction techniques, including a
radiofrequency-powered sheath used in 78 of 109 leads. Successful extraction was achieved in 80% (162/203)
of all leads and 94% (103/109) of leads undergoing a complex extraction. On multivariable analysis, older lead
Results age (odds ratio [OR], 0.63; 95% confidence interval [CI], 0.48 to 0.82; P<0.0001), ventricular lead position
(OR, 0.40; 95% CI, 0.20 to 0.79; P=0.015), and polyurethane insulation (OR, 0.34; 95% CI, 0.14 to 0.80;
P=0.017) were found to be associated with a decreased likelihood of simple extraction.
Safety results: There were 4 major and 4 minor procedural complications involving 8 patients and no
procedure-related deaths. On univariate analysis, lead age (OR, 1.28; 95% CI, 1.09 to 1.50; P=0.002) was the
only factor associated with procedural complications.
Relevance: Related; The manufacturer of the nonlocking stylets and anchoring sleeves was not specified.
Limitations: The manufacturer of the accessories was not specified.
Critical Conclusion: The majority of leads implanted in pediatric and congenital heart disease patients can be extracted
Evaluation successfully; however, the procedure carries a risk of serious complications. Older lead age, ventricular leads,
and polyurethane insulation were independent predictors of the decreased likelihood of an extraction by simple
traction.
9
Hillock Richard J, Stevenson Irene H, Mond Harry G. The right ventricular outflow tract: a comparative
Full
study of septal, anterior wall, and free wall pacing. Pacing and clinical electrophysiology - PACE.
Citation
2007;30(8):942-947.
Objective: To identify a reproducible way of placing a ventricular lead onto the RV outflow tract (RVOT)
septum.
Device: Introducers, stylets
Study Indication: Complete heart block or high grade AV block in 14 patients, symptomatic bradycardia in 11, and
summary syncope thought to be due to bradycardia in 3.
Type of study: Retrospective, observational
N: 28 patients
Follow-up: Acute
Performance results: All leads were loaded with a stylet fashioned with a distal primary curve to facilitate
delivery of the lead to the pulmonary artery, then using a pullback technique the lead was retracted to the
RVOT. All lead placements were confirmed by fluoroscopy and electrocardiography. Anterior or free wall
placement was achieved by the stylet having either the standard curve or an added distal anterior angulation. In
Results contrast, septal lead positioning was uniformly achieved by a distal posterior angulation of the curved stylet.
This difference in tip shape was highly predictive for septal placement (P < 0.001). With septal pacing, a
narrower QRS duration was noted, compared to anterior or free wall pacing (136 vs 155 ms, P < 0.001). All
pacing parameters were within acceptable limits.
Safety results: No safety outcomes were reported.
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Relevance: Related; The manufacturers of accessories were not specified, although a number of the implanted
leads were manufactured by Medtronic.
Limitations: 1) This was a retrospective, observational study. 2) The manufacturer of the accessories was not
Critical
specified.
Evaluation
Conclusion: Using appropriately shaped stylets, pacing leads can now be placed into specific positions within
the RVOT and in particular septal pacing can be reliably and reproducibly achieved. This is an important step
in the standardization of lead placement in the RVOT.
10
Full Mazzone P, Tsiachris D, Marzi A, et al. Advanced techniques for chronic lead extraction: Heading from
Citation the laser towards the evolution system. Europace. 2013;15(12):1771-1776.
Objective: To compare retrospectively and indirectly the efficacy and the safety of the evolution system vs.
the established laser system in cases where advanced extraction tools are required.
Device: Standard stylet, locking stylet (Cook Vascular Inc), telescoping dilator sheath set leads, powered
sheath (CVX-300 Excimer laser system, Spectranetics Co.) or evolution mechanical dilator sheath (Cook
Study Medical), and snares (Andrasnare, Andramed GmbH) or Needle’s eye snare (Cook Vascular) as needed
summary Indication: Patients indicated for lead extraction
Type of study: Prospective
N: 208 patients, 23 with simple traction (manual and/or standard stylet)
Follow-up: Acute
Performance results: Extraction was achieved with simple traction (manual and/or using standard stylet) in
23 patients, by means of locking stylet in 51 patients, while a telescoping dilator sheath set leads was used in
Results 11 patients, and a powered sheath (laser or evolution) in 121 patients.
Safety results: No stylet-related safety outcomes were reported.
Relevance: Related; The manufacturer of the stylets was not specified.
Limitations: 1) Focus of the article was a comparison of powered sheath tools. 2) The manufacturer of the
standard stylets was not specified. 3) Small number of patients who achieved extraction via simple traction;
Critical
additionally, the number of extractions performed with standard stylet was not specified.
Evaluation
Conclusion: Use of the recently introduced evolution system for LE exhibit acceptably high levels of safety, as
well as of procedural and clinical success, although additional use of snare was required more frequently in the
evolution compared with the laser group.
11
Full Mond Harry G, Feldman A, Kumar S, Rosso R, Hung Thuy T, Pang B. Alternate site right ventricular
Citation pacing: defining template scoring. Pacing and clinical electrophysiology - PACE. 2011;34(9):1080-1086.
Objective: This study examined a method of evaluating alternate RV pacing sites using a template scoring
system based on measuring the angle of lead attachment in the 40° LAO fluoroscopic view and its effect on
altering the loop of lead in the RV.
Device: Stylet designed for septal placement (Model 4140, St. Jude Medical)
Study Indication: The indications for the pacemaker were high-grade AV block in nine, sick sinus syndrome in
summary seven, paroxysmal or established atrial fibrillation in five, and syncope of unknown cause in two.
Type of study: Prospective
N: 23 patients
Follow-up: Acute
Performance results: Successful positioning of pacing leads at the RVOT septum (18 patients) and mid-RV
septum (five patients) was achieved. With introduction of more lead into the RV chamber, the angle of
attachment in the LAO projection altered over a range of 6°-32° for all patients with a mean of 14.6 ± 6.6°. In
Results 87% of patients, the range was predominantly within the same template score with only minor overlap into
another zone.
Safety results: Safety outcomes were not presented.
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Relevance: Related; Article discusses the use of competitive stylets.

Limitations: 1) Small number of patients 2) Not actual device
Critical
Evaluation Conclusion: This study shows that the angle of lead attachment in the RV is altered by introducing more lead,
but in most cases, the template score remains the same. Further studies are required to determine the accuracy
and efficacy of the templates.
12
Full Mora G. A novel method of placing right ventricular leads in patients with persistent left superior vena
Citation cava using a conventional J stylet. Indian Pacing and Electrophysiology Journal. 2014;14(2):65-74.

Objective: To evaluate a technique for the implanting of ventricular electrode in patients with persistent left
superior vena cava (LSVC).
Device: Conventional J stylet (St Jude Medical and Boston Scientific)
Study Indication: Pacemaker or cardiac defibrillator patients with persistent LSVC
summary
Type of study: Prospective
N: 5 patients
Follow-up: 6 months – 5 years
Performance results: All procedures were successfully completed and patients have been follow-up for up to
5 years with suitable functioning parameters.
Results
Safety results: Fluoroscopy time for implanting the ventricular electrode ranged from 60 to 250 seconds, 40 to
92 minutes being taken to complete the whole procedure.
Relevance: Related; Article discusses the use of competitive stylets.
Critical Limitations: 1) Small number of patients 2) Not actual device
Evaluation Conclusion: The authors present a simple and rapid technique for electrode placement in patients with LSVC
using usual J guide and active fixation electrodes with high success.
13
Full Rosso R, Medi C, Teh Andrew W, et al. Right ventricular septal pacing: a comparative study of outflow
Citation tract and mid ventricular sites. Pacing and clinical electrophysiology - PACE. 2010;33(10):1169-1173
Objective: The purpose of this study was to compare the QRS morphology, duration, and suitability of RVOT
septal and mid-RV septal pacing.
Device: A specifically shaped J stylet designed to facilitate positioning of active fixation ventricular leads onto
the RV septum (Mond Stylet model 4140, St. Jude Medical) was used for all RV lead implants.
Study
summary Indication: Dual-chamber pacemaker patients
Type of study: Prospective
N: 17 consecutive patients
Follow-up: Acute
Performance results: Successful positioning of the pacing leads at the RVOT septum and mid-RV septum
was achieved in 15 patients (88.2%). There were no significant differences in the mean stimulation threshold,
Results R-wave sensing, and lead impedance between the two sites. The QRS duration in the RVOT septum was 151 ±
14 ms and in the mid-RV septum 145 ± 13 ms (P = 0.150).
Safety results: Safety outcomes were not reported
Relevance: Related; Article discusses the use of a competitive stylet
Limitations: 1) Small number of patients 2) Not actual device
Critical
Evaluation Conclusion: This prospective observational study shows that septal pacing can be reliably achieved both in the
RVOT and mid-RV with active fixation leads using a specifically shaped stylet. There are no preferences in
regard to acute lead performance or paced QRS duration with either position.
14
Full Rosso R, Teh Andrew W, Medi C, Hung Thuy T, Balasubramaniam R, Mond Harry G. Right ventricular
Citation septal pacing: the success of stylet-driven active-fixation leads. PACE. 2010;33(1):49-53.
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Objective: The aim of this study was to evaluate the effectiveness of the stylet-driven technique in septal lead
placement guided only by posterior-anterior (PA) fluoroscopic view.
Device: A specifically shaped J stylet designed to facilitate positioning of active fixation ventricular leads onto
the RV septum (Mond Stylet model 4140, St. Jude Medical) was used for all RV lead implants.
Study
summary Indication: Single or dual-chamber pacemaker patients
Type of study: Prospective
N: 100 consecutive patients
Follow-up: Acute
Performance results: The RV lead position was septal in 90% of the patients. This included mid RV in 56 and
RVOT in 34 patients. There were no significant differences in the mean stimulation threshold, R-wave sensing,
Results and lead impedance between the two sites. In the RVOT, 97% (34/35) of leads were placed on the septum,
whereas in the mid RV the value was 89% (56/63).
Safety results: There were no known patient deaths related to pacemaker complications.
Relevance: Related; Article discusses the use of a competitive stylet
Critical Limitations: Not actual device
Evaluation Conclusion: The study confirms that conventional active-fixation pacing leads can be successfully and safely
deployed onto the RV septum using a purposely-shaped stylet guided only by the PA fluoroscopic projection.
15
Full Vlay SC. Right Ventricular Outflow Tract Pacing: Practical and Beneficial. A 9-year Experience of
Citation 460 consecutive Implants. PACE 2006; 29:1055-1062.
Objective: The author describes his 9 year experience of pacing implants with the intent to position the lead in
the RVOT.
Device: Straight stylet, stylet with S-curve
Study Indications: Symptomatic bradycardia or heart block
summary
Type of study: Observational
Number of patients: 460 patients
Follow-up: 1-9 years; the author personally continues to follow-up 130 of the 460 patients.
Performance results: The overall success rate in the RVOT was 84% over the total 9-year period with a 92%
success rate in the last 4 ½ years, using the RVOT technique described. At 20 months in a subgroup
Results comparison of RVOT and RVA implants, there was no significant difference in pacing threshold, R-wave
sensing, or pacing lead impedance.
Safety results: Dislodgment occurred in only 1 of 460 patients.
Relevance: Related; The manufacturer of the stylets was not specified; however the manufacturer of the leads
was Medtronic. Therefore, it is assumed that the manufacturer of the stylets also was Medtronic.
Limitations: 1) This was a single-operator experience. 2) The manufacturer of the accessories was not
specified.
Critical
Evaluation Conclusions: Reasons for failure to implant in the RVOT include inability to find a stable position with
adequate pacing and sensing thresholds (related to anatomy, scarred myocardium, pulmonary hypertension,
tricuspid regurgitation), hemodynamic instability limiting time for implant, and a learning curve. Long-term
stability and lead performance were excellent, and certain acute and chronic complications of RV pacing did
not occur.
4
Full Worley Seth J, Gohn Douglas C. Prolapsed double-canted bipolar left ventricular lead for pacing the left
Citation atrium via the coronary sinus: experience in 11 patients. Europace. 2012;14(3):445-448.
Study Objective: The aim of this report is to describe a method for and the results of prolapsing a double-canted
summary bipolar lead into the mid-to-distal CS to eliminate lead dislodgement and improve pacing thresholds.
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Device: The LA and RA leads were connected via a bipolar adapter (2872 lead adapter kit Medtronic, Inc.) and
the IS-1 connector of the adapter inserted in the atrial output of the implantable cardioverter defibrillator (ICD;
InSync Sentry 7297 and 7299 Medtronic, Inc.).
Indications: CRT patients
Type of study: Prospective
Number of patients: 11 patients
Follow-up: 6-10 months
Performance results: After CS access the 9 Fr. anatomic sheath is withdrawn to the RA over an extra support
wire. A double-canted bipolar lead is advanced into the RA until the proximal bend is outside the tip of the
sheath. With the stylet withdrawn to the proximal bend, the sheath and lead are advanced over the wire back
into the CS. The lead distal to the proximal bend is prolapsed beside the sheath as the tip of the sheath enters
Results the CS. The lead was successfully prolapsed in 11 consecutive patients. In one patient, capture was >5 V in all
locations. Of the 10 successful implants, the acute thresholds were: mean 1.53 V, median 1.35 V, range 0.4-4.0
V. Chronic thresholds were: mean 2 V, median 2 V range 0.4-4.0 V.
Safety results: There were no displaced leads or lead fractures through 6-10 months of follow-up.
Relevance: Relevant; model 2872 is used, but only 11 patients were included.
Limitations: Small number of patients
Critical
Evaluation Conclusion: Prolapse of a commercially available double-canted bipolar passive fixation lead eliminates lead
dislodgment and improves thresholds providing a means for permanent pacing of the LA from the mid to distal
CS and provides the design principles for a dedicated lead.
16
Full Yee R, Gadler F, Hussin A, et al. Novel active fixation mechanism permits precise placement of a left
Citation ventricular lead: early results from a multicenter clinical study. Heart rhythm. 2014;11(7):1150-1155.
Objective: To assess the feasibility and safety of the Model 20066 left ventricular (LV) lead and to evaluate
the implant procedure.
Device: Stylet
Study Indication: Standard indications for CRT
summary
Type of study: Prospective, nonrandomized, multicenter investigational study
N: 40 patients
Follow-up: 12 months
Performance results: The lead was successfully implanted in 39 of 40 (98%) patients. In 38 of 40 (95%)
patients, the implanters were successful at implanting at a predetermined target site. The electrical performance
of the tip and ring electrodes was stable through the 12-month follow-up visit and similar to other LV leads.
Overall lead handling was rated as acceptable for all implants.
Results Safety results: Four patients died of causes unrelated to the LV lead or the CRT system at 6, 9, 12, and 14
months postimplant. During follow-up, there were no Model 20066 LV lead dislodgements reported; 1
patient’s lead showed increasing pacing impedance and loss of capture at the tip electrode which resulted in the
lead being extracted (no cause for the rising impedance and pacing threshold was identified); there was also 1
instance of diaphragmatic stimulation postimplant that was resolved noninvasively by reprogramming.
Relevance: Related; The manufacturer of the stylets was not specified; however the manufacturer of the leads
was Medtronic. Therefore, it is assumed that the manufacturer of the stylets also was Medtronic.
Critical Limitations: 1) The implant procedure could be performed with either a stylet or a guidewire. 2) The
Evaluation manufacturer or model of the accessories was not specified.
Conclusion: This new LV lead specifically designed with an active fixation mechanism for stability and
precise placement was successfully and safely deployed in the coronary vasculature.
17
Full Yusu S, Mera H, Hoshida K, et al. Selective site pacing from the right ventricular mid-septum. Follow-
Citation up of lead performance and procedure technique. Int. Heart J. 2012;53(2):113-116.
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Objective: To attempt to pace from the RV mid-septum, which is theoretically a more physiological pacing
site.
Device: A screw-in lead and a curved stylet were used for lead positioning on the RV mid-septum.
Study Indications: Permanent pacemaker patients
summary
Type of study: Prospective
Number of patients: 165 patients
Follow-up: one year
Performance results: Lead placement was successful in all patients of RV mid-septal pacing. There were no
technical problems during or after the procedure. The cumulative percentage of ventricular pacing at one year
postimplantation was 85 ± 24 % in the selective site pacing (SSP) group. Sensing, pacing threshold, and lead
impedance in the SSP group remained clinically stable over one year. When these measurements were
Results compared between the SSP and apex pacing (AP) groups, the pacing threshold and the lead impedance at one
year postimplantation in the SSP group were higher (P < 0.05) and lower (P < 0.01), respectively, than those of
the AP group. The mean QRS duration was markedly shorter (123 ± 16 versus 150 ± 18 msec, P < 0.0001).
Safety results: Safety outcomes were not presented.
Relevance: Related; The manufacturer of stylet was not specified.
Limitations: The manufacturer of the accessories was not specified.
Critical
Evaluation Conclusion: Selective site pacing from the RV mid-septum is feasible and results in less conduction delay
compared to conventional RV apical pacing, and its procedure seems to be more physiological in permanent
pacemaker implantation.
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4 Appendix E – Clinical experience data

4.1 Overview
This appendix contains post market surveillance data representing actual field experience as accurately
as possible based upon the information provided to Medtronic. Data was limited to clinically relevant
field corrective actions and medical device vigilance reports. All known favorable and unfavorable data
were included. The results are provided below.
Table 7 provides an overview of the post market surveillance data for the Medtronic and Vitatron
general lead accessories. The specific reporting period is from date of first commercialization to 31 Jan
2016. The data included in tables in this section were compiled from Medtronic's Global Complaint
Handling System (GCH), sales/distribution system SAP (Systems, Applications, and Products for Data
Processing) and field corrective action system EFAS (Enterprise Field Action System).
Table 7: Worldwide Post Market Surveillance Data Summary

Clinically Medical Device

Regulatory Reporting Vigilance*
Sales / Relevant Field
Model Numbers Approval Date Period End
Distribution Corrective (as a percentage
or Release Date Date
Actions of sales)
2872 5 Nov 1997 31 Jan 2016 17,487 0 22 (0.126%)
5019 7 Oct 2011 31 Jan 2016 442 0 2 (0.452%)
5866-23, 5866-
24M, 5866-38M, 01 Jan 1993 31 Jan 2016 153,240 0 39 (0.025%)
5866-40M
5867-2, 5867-3M,
13 Dec 1994 31 Jan 2016 518,305 0 6 (0.001%)
5867-5
5873C, 5873W 13 Dec 1994 31 Jan 2016 1,356,093 0 2 (0%)
6048 13 Dec 1994 31 Jan 2016 53,764 0 0 (0%)
6052 13 Dec 1994 31 Jan 2016 48,166 0 0 (0%)
6054 13 Dec 1994 31 Jan 2016 91,051 0 1 (0.001%)
6057 13 Dec 1994 31 Jan 2016 123,556 0 7 (0.006%)
6082 13 Dec 1994 31 Jan 2016 255,575 0 4 (0.002%)
6091 10 Oct 1996 31 Jan 2016 38,831 0 0 (0%)
6093 22 Jan 1998 31 Jan 2016 54,692 0 2 (0.004%)
6094 13 Feb 1997 31 Jan 2016 50,263 0 4 (0.008%)
6230UNI 31 Jan 2016 31 Jan 2016 121,373 0 7 (0.006%)
6232ADJ 31 Jan 2016 31 Jan 2016 211,749 0 9 (0.004%)
6254 27 Apr 2001 31 Jan 2016 13,314 0 0 (0%)
6282 27 Apr 2001 31 Jan 2016 25,210 0 0 (0%)
6293 27 Apr 2001 31 Jan 2016 12,326 0 0 (0%)
6701 13 Dec 1994 31 Jan 2016 12,045 0 0 (0%)
6707 13 Dec 1994 31 Jan 2016 4,544 0 13 (0.286%)
6719 13 Dec 1994 31 Jan 2016 28,083 0 0 (0%)
6725 09 Jul 2001 31 Jan 2016 128,711 0 6 (0.005%)
6726 30 Nov 2001 31 Jan 2016 4,158 0 5 (0.12%)
6920 01 Jan 1993 31 Jan 2016 2,544 0 0 (0%)
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Clinically Medical Device

Regulatory Reporting Vigilance*
Sales / Relevant Field
Model Numbers Approval Date Period End
Distribution Corrective (as a percentage
or Release Date Date
Actions of sales)
6981M 01 Jan 1993 31 Jan 2016 3,577 0 6 (0.168%)
6984M 01 Jan 1993 31 Jan 2016 12,688 0 26 (0.205%)
6985M 01 Jan 1993 31 Jan 2016 5,119 0 5 (0.098%)
6986M 01 Jan 1993 31 Jan 2016 932 0 3 (0.322%)
VIK 10D1, VIK
10S1, VIK 10S5,
VIK11 D1, VIK
11S1, VIK 11S5,
VIK 12D1, VIK
12S1, VIK 12S5, 01 Apr 2001 31 Jan 2016 222,975 0 1 (0%)
VIK 7D1, VIK 7S1,
VIK 7S5, VIK 8D1,
VIK 8S1, VIK 8S5,
VIK 9D1, VIK 9S1,
VIK 9S5
6207BTK-1,
6207BTK-5,
6207BTK-D1,
6207BTKL-1,
6208BTK-1,
6208BTK-5,
6208BTK-D1,
6208BTKL-1,
6209BTK-1,
6209BTK-5,
6209BTK-D1,
6209BTKL-1, 01 Mar 1995 31 Jan 2016 778,485 0 7 (0.001%)
6210BTK-1,
6210BTK-5,
6210BTK-D1,
6210BTKL-1,
6211BTK-1,
6211BTK-5,
6211BTK-D1,
6212BTK-1,
6212BTK-5,
6214BTK-1,
6214BTK-5
6207-D1, 6207-S1,
6207-S5, 6208-D1,
6208-S1, 6208-S5,
6209-D1, 6209-S1,
6209-S5, 6210-D1,
07 May 1999 31 Jan 2016 2,988,969 0 19 (0.001%)
6210-S1, 6210-S5,
6211-D1, 6211-S1,
6211-S5, 6212-S1,
6212-S5, 6214-S1,
6214-S5
6056 13 Dec 1994 31 Jan 2016 195,949 0 0 (0%)
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Clinically Medical Device

Regulatory Reporting Vigilance*
Sales / Relevant Field
Model Numbers Approval Date Period End
Distribution Corrective (as a percentage
or Release Date Date
Actions of sales)
6056M 14 Dec 2010 31 Jan 2016 16,874 0 0 (0%)
80118 13 Dec 1994 31 Jan 2016 156,820 0 1 (0.001%)
All Model Summary 7,707,910 0 197 (0.003%)

*Note: Medical Device Vigilance is the count of events that resulted in a report to a regulatory agency anywhere in the
world, excluding events associated with a clinically relevant field action. A single event may be required to be reported
to more than one agency; it is counted only once in this table.

4.2 Sales and distribution data

Worldwide sales data is summarized in Table 8.
Table 8: Worldwide Sales / Distribution

United Rest of
Model Numbers Europe* Australia Canada Japan Sum
States World
2872 5,357 18 226 6 7,564 4,316 17,487
5019 165 3 10 7 251 6 442
5866-23, 5866-
24M, 5866-38M, 21,097 169 5,385 3,453 61,866 61,270 153,240
5866-40M
5867-2, 5867-3M,
145,192 4,804 25,526 21,070 275,511 46,202 518,305
5867-5
5873C, 5873W 270,410 6,497 46,206 122,708 851,406 58,866 1,356,093
6048 18,165 88 1,563 0 25,056 8,892 53,764
6052 18,133 240 2,090 1,038 17,100 9,565 48,166
6054 27,394 487 3,051 4,082 46,490 9,547 91,051
6057 20,283 448 3,597 12,838 80,144 6,246 123,556
6082 59,636 1,115 8,363 34,296 141,593 10,572 255,575
6091 12,242 278 1,266 13 23,365 1,667 38,831
6093 20,233 672 2,265 1,636 26,280 3,606 54,692
6094 13,479 148 1,738 2,890 30,578 1,430 50,263
6230UNI 34,239 895 6,651 1,368 69,876 8,344 121,373
6232ADJ 55,584 874 2,433 12,290 113,077 27,491 211,749
6254 6,985 17 1,302 572 3,034 1,404 13,314
6282 11,798 27 1,598 2,596 8,020 1,171 25,210
6293 7,238 172 160 964 3,065 727 12,326
6701 4,389 7 1,627 0 4,356 1,666 12,045
6707 429 0 66 0 1,915 2,134 4,544
6719 12,277 188 2,295 1,951 8,365 3,007 28,083
6725 44,022 1,525 6,998 0 67,820 8,346 128,711
6726 1,197 1 130 1 2,668 161 4,158
6920 537 2 104 0 1,111 790 2,544
6981M 989 6 66 107 679 1,730 3,577
6984M 4,455 109 491 748 4,505 2,380 12,688
6985M 347 0 160 790 2,479 1,343 5,119
6986M 174 1 46 9 378 324 932
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VIK 10D1, VIK

10S1, VIK 10S5,
VIK11 D1, VIK
11S1, VIK 11S5,
VIK 12D1, VIK
12S1, VIK 12S5,
144,533 0 0 0 10,077 68,365 222,975
VIK 7D1, VIK
7S1, VIK 7S5,
VIK 8D1, VIK
8S1, VIK 8S5,
VIK 9D1, VIK
9S1, VIK 9S5
6207BTK-1,
6207BTK-5,
6207BTK-D1,
6207BTKL-1,
6208BTK-1,
6208BTK-5,
6208BTK-D1,
6208BTKL-1,
6209BTK-1,
6209BTK-5,
6209BTK-D1,
6209BTKL-1, 278,611 35,833 25,148 131,511 128,032 179,350 778,485
6210BTK-1,
6210BTK-5,
6210BTK-D1,
6210BTKL-1,
6211BTK-1,
6211BTK-5,
6211BTK-D1,
6212BTK-1,
6212BTK-5,
6214BTK-1,
6214BTK-5
6207-D1, 6207-S1,
6207-S5, 6208-D1,
6208-S1, 6208-S5,
6209-D1, 6209-S1,
6209-S5, 6210-D1,
1,319,999 29,561 96,912 0 428,428 1,114,069 2,988,969
6210-S1, 6210-S5,
6211-D1, 6211-S1,
6211-S5, 6212-
S1, 6212-S5,
6214-S1, 6214-S5
6056 50,668 707 9,219 7,660 119,928 7,767 195,949
6056M 5,343 223 1,200 1,704 7,167 1,237 16,874
80118 32,367 170 1,900 1,454 89,163 31,766 156,820
Sum 2,647,967 85,285 259,792 367,762 2,661,347 1,685,757 7,707,910
* Note: Europe includes EU Member States as well as Albania, Andorra, Armenia, Azerbaijan, Belarus, Bosnia And
Herzegovina, Georgia, Iceland, Liechtenstein, The Former Yugoslav Republic of Macedonia, Moldova, Monaco,
Montenegro, Norway, San Marino, Serbia, Switzerland, Turkey, Ukraine, Vatican City State.
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4.3 Clinically relevant field corrective actions

Clinically relevant field corrective actions refer to field actions that reduce the safety risk for implanted
patients (e.g. recall, modification, withdrawal or removal of implanted product from the market).
Medtronic CRHF has a process in place that classifies field corrective actions as ‘clinically significant’
based on product safety risk associated with the issue impacting a medical device in accordance with EN
ISO 14971:2012. Since the release of the models listed in Table 1, there have been 0 clinically
significant field corrective actions.

4.4 Medical device vigilance

This section contains an overview of the medical device vigilance reports associated with the Medtronic
and Vitatron lead accessories included in this report. The medical device vigilance category is defined as
events that resulted in a report to a regulatory agency anywhere in the world. This includes serious
adverse events and deaths. These events have well-defined reporting criteria and represent the clinical
use of Medtronic devices in multiple geographies. Therefore, this data can be valuable for gaining
insight into clinical performance (e.g., the incidence of complications such as infection, muscle
stimulation, etc.).
The following table shows the number of regulatory reports submitted for each model as well as the
corresponding number of unique product events during this reporting period.
Table 9: Worldwide Medical Device Vigilance Summary

Worldwide Unique Worldwide

Model
Events Regulatory Reports
2872 22 22
5019 2 3
5866-23, 5866-24M, 5866-38M, 5866-40M 39 41
5867-2, 5867-3M, 5867-5 6 6
5873C, 5873W 2 6
6048 0 0
6052 0 0
6054 1 1
6057 7 7
6082 4 5
6091 0 0
6093 2 2
6094 4 4
6230UNI 7 7
6232ADJ 9 9
6254 0 0
6282 0 0
6293 0 0
6701 0 0
6707 13 18
6719 0 0
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Worldwide Unique Worldwide

Model
Events Regulatory Reports
6725 6 6
6726 5 6
6920 0 0
6981M 6 6
6984M 26 31
6985M 5 5
6986M 3 3
VIK 10D1, VIK 10S1, VIK 10S5, VIK11 D1, VIK
11S1, VIK 11S5, VIK 12D1, VIK 12S1, VIK 12S5,
1 1
VIK 7D1, VIK 7S1, VIK 7S5, VIK 8D1, VIK 8S1,
VIK 8S5, VIK 9D1, VIK 9S1, VIK 9S5
6207BTK-1, 6207BTK-5, 6207BTK-D1, 6207BTKL-
1, 6208BTK-1, 6208BTK-5, 6208BTK-D1,
6208BTKL-1, 6209BTK-1, 6209BTK-5, 6209BTK-
D1, 6209BTKL-1, 6210BTK-1, 6210BTK-5, 7 7
6210BTK-D1, 6210BTKL-1, 6211BTK-1, 6211BTK-
5, 6211BTK-D1, 6212BTK-1, 6212BTK-5,
6214BTK-1, 6214BTK-5
6207-D1, 6207-S1, 6207-S5, 6208-D1, 6208-S1,
6208-S5, 6209-D1, 6209-S1, 6209-S5, 6210-D1,
19 19
6210-S1, 6210-S5, 6211-D1, 6211-S1, 6211-S5,
6212-S1, 6212-S5, 6214-S1, 6214-S5
6056 0 0
6056M 0 0
80118 1 1
Sum 197 216

A listing by event description for each model and major geography is presented in Table 10 -
Table 34. The event descriptions included below include categories for the patient impact or
consequence of the event (e.g. dizziness/dyspnea/lethargy) as well as categories related to
complaints regarding the products that may have had no patient impact or consequence (e.g.
diagnostics). For Table 10 - Table 34: TGA IR
= Therapeutic Goods Administration Incidence Report; MDPR = Medical Device Problem
Report; PMDA = Pharmaceuticals and Medical Devices Agency; MDR = Medical Device
Report.
As presented in Table 7 and Table 9, there were 197 unique events (0.003% as a percentage of
sales) for these models, which resulted in 216 regulatory reports (one event can generate a report
to more than one regulatory body). In addition, each report may have been assigned more than
one event description (i.e., one event could have 2 event descriptions: infection and death). Note:
In the event description titled ‘death’, Medtronic did not determine a causal relationship between
the product and the patient’s death; however, the deaths are included since they are required
reportable events per the regulations in certain geographies.