BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead)
Total Reports
100
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Inappropriate Shock from Noise Oversensing
noise, shock, effects, service, inappropriate
1
reports
Product Performance Issue with Explant
report reflects, received fda, fda form, form notification, notification
1
reports
Right Ventricular Lead Impedance Issue
form, intervention, capped, low, patient consequences
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
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