BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
132
Reports (30d)
6
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
4
reports
Inappropriate Shock from Oversensing
additional information, received file, file updated, inappropriate, shocks
3
reports
Explanted Lead Due to Infection
additional information, infection additional, received file, available file, file updated
2
reports
Explanted Lead for Unknown Reason
effects, reported right, additional adverse, explanted replaced, new lead
1
reports
Failed Implant Attempt Due to Helix Issue
lead implanted, stable, new lead, implant procedure, helix
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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