BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
1,176
Reports (30d)
11
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Inappropriate Shock from Oversensing
additional information, received file, file updated, inappropriate, shocks
11
reports
Noise Observed on Implanted Lead
additional information, received file, file updated, implanted additional, remains implanted
4
reports
Fractured Lead Capped
file, received file, file updated, updated lead, reported additional
3
reports
Explanted Lead Due to Infection
additional information, infection, infection additional, received file, available file
3
reports
Explanted Lead Due to Noise
events, file, file updated, updated lead, reported additional
2
reports
Out-of-Range Shock Impedance Monitoring
received file, file updated, shock impedance, ohms, remains implanted
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Conductor cable externalization in an atrial hemodynamic sensor lead in a patient presenting with inappropriate shocks.
Yap SC, et al. · 2019
Citations indexed from PubMed.
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