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
582
Reports (30d)
16
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
ICD System Revision for Infection
additional information, infection additional, pocket, effects, additional adverse
18
reports
Unexpected Battery Behavior in Device
currently, battery, additional information, device remains, remains implanted
9
reports
ICD Explanted for EOS Indication
currently, battery, additional information, device remains, remains implanted
4
reports
Device Explanted for ERI Status
replacement, additional information, normal, showed, stable
2
reports
Electrode Revision Due to Infection
infection additional, effects, electrode, additional adverse, inappropriate
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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