Rivacor 7 HF-T QP DF4 IS4 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · CRT-Defibrillator (CRT-D)
Total Reports
311
Reports (30d)
4
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Explanted Due to ERI Status
battery, device remains, explanted replaced, remains, explanted
5
reports
Explanted Due to Bacteremia Infection
infection, patient stable, procedure patient, patient complications, explanted
2
reports
Device in Backup Mode Post-MRI
support contacted, resolve event, technical support, mri, mode
1
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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