BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024
Total Reports
116
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
ICD Explanted Due to ERI Status
currently, additional information, field, showed, remains implanted
3
reports
ICD at ERI with Battery Behavior
remains implanted, currently, adverse, battery, additional information
2
reports
ICD Explanted Due to EOS Status
remains implanted, shocks, adverse, battery, additional information
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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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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