BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
665
Reports (30d)
7
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Explanted Lead Due to Infection
additional information, infection additional, received file, file updated, explanted infection
2
reports
Out-of-Range Shock Impedance Monitoring
received file, file updated, shock impedance, ohms, remains implanted
2
reports
Template Summary: FDA Notification
report reflects, received fda, reflects information, fda form, form notification
2
reports
Capped Lead from Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
1
reports
Fractured Lead Capped
file, received file, file updated, updated lead, reported additional
1
reports
Inappropriate Shock from Oversensing
additional information, received file, file updated, inappropriate, shocks
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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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