BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1993
Total Reports
3,266
Reports (30d)
91
Active Signals
2
Open Recalls
4
What the reports describe · Claripulse analysis
Right Lead Revision for Infection
explanted right, infection additional, effects, reported lead, revision infection
39
reports
High Shock Impedance Measurements
defibrillator crt, cardiac resynchronization, crt, remains service, effects
37
reports
Failed Implant Attempt Due to Helix Issue
lead implanted, stable, new lead, implant procedure, helix
21
reports
Dislodged Lead with High Capture Threshold
remains service, effects, reported right, additional adverse, capture
16
reports
Oversensed Noise on ICD Channel
implantable cardioverter, icd, cardioverter, effects, cardioverter defibrillator
12
reports
Implantable Lead Revision for Infection
adverse, effects, revision infection, implantable, lead revision
10
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Evidence
Biventricular pacing and coronary sinus ICD lead implantation in a patient with a mechanical tricuspid valve replacement.
Srinivasan NT, et al. · 2015
Precision in Action: Using Intracardiac Echocardiography for Targeted Removal of a Large Lead-Related Vegetation in a Patient With Infective Endocarditis.
Memon M, et al. · 2025
A method for successfully implanting an implantable cardioverter-defibrillator wrapped with an expanded polytetrafluoroethylene sheet in a patient with metal allergy.
Morishita K, et al. · 2023
[ICD electrode implantation for left bundle branch area pacing].
Imnadze G, et al. · 2025
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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