Rivacor 7 HF-T QP DF4 IS4 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · CRT-Defibrillator (CRT-D)
Total Reports
319
Reports (30d)
8
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Explanted Due to ERI with Battery Issues
battery, additional information, resolve event, patient stable, explanted
6
reports
Device Explanted Due to ERI Status
additional information, resolve event, device reprogrammed, explanted replaced, explanted
4
reports
System Explanted Due to Infection
additional information, infection, patient stable, following, explanted
2
reports
Device in Backup Mode After MRI
support contacted, resolve event, technical support, mri, mode
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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