BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Mar 2008
Total Reports
225
Reports (30d)
2
Active Signals
1
Open Recalls
4
What the reports describe · Claripulse analysis
Explanted ICD Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
2
reports
Explanted Lead for Unknown Reason
effects, reported right, additional adverse, explanted replaced, new lead
1
reports
High Shock Impedance Leading to Revision
high range, effects, additional adverse, range shock, impedance measurements
1
reports
High Shock Impedance Measurements
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
1
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
Disparity in left ventricular stimulation among different pacing configurations in cardiac resynchronization therapy.
Huizar JF, et al. · 2011
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. 1 active signal detected right now.
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