BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
127
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Inappropriate Shock from Oversensing
additional information, received file, file updated, inappropriate, shocks
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Clinical safety of the ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 3 T: results of the ProMRI 3T ENHANCED Master study.
Zbinden R, et al. · 2019
Cardiac resynchronization therapy in persistent left superior vena cava: Can you do it two-leads-only?
Biffi M, et al. · 2016
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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