Rivacor 7 HF-T QP DF4 IS4 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · CRT-Defibrillator (CRT-D)
Total Reports
304
Reports (30d)
5
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Explanted Due to Unexpected Battery Behavior
battery, additional information, lead, remains, explanted
6
reports
Device Explanted Due to Infection
additional information, infection, infection additional, consequences reported, explanted
2
reports
Left Ventricular Lead Dislodged and Replaced
left, lead, replaced, left ventricular, capture
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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