Acticor 7 VR-T DX DF4 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024
Total Reports
612
Reports (30d)
12
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Infection Leading to Device Explant
additional information, infection, pocket, effects, additional adverse
12
reports
Unexpected Battery Behavior Detected
battery, additional information, device remains, remains implanted
11
reports
Device Explanted Due to ERI Behavior
battery, additional information, device remains, remains implanted
5
reports
Device Explanted Due to ERI Status
observed, replacement, normal, showed, stable
3
reports
Device Interrogation Failure Reported
clinic, stable, device remains, remains implanted, technical
2
reports
Device Explanted Due to EOS Status
battery, additional information, showed, detected, remains implanted
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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