BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
506
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Capped Lead from Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
1
reports
Explanted Lead Due to Noise
events, file, file updated, updated lead, reported additional
1
reports
Noise Observed on Implanted Lead
additional information, received file, file updated, implanted additional, remains implanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Remarkably high and accelerating failure rate of a widely used implantable cardioverter-defibrillator lead: A large-scale manufacturer-independent multicenter study with long accurate follow-up.
Oosterwerff EFJ, et al. · 2024
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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