BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
197
Reports (30d)
14
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Explanted Lead Due to Dislodgement
additional information, received file, dislodgement, file updated, updated lead
20
reports
Explanted Lead Due to Infection
additional information, infection, infection additional, received file, available file
14
reports
Explanted Lead Due to Noise
events, file, file updated, updated lead, reported additional
2
reports
Inappropriate Shock from Oversensing
additional information, received file, file updated, inappropriate, shocks
2
reports
Fractured Lead Capped
file, received file, file updated, updated lead, reported additional
1
reports
Out-of-Range Shock Impedance Monitoring
received file, file updated, shock impedance, ohms, 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
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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