Intica 7 VR-T DX DF-1 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024
Total Reports
382
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Replaced Due to ERI Indication
battery, replacement, additional information, alert, explanted replaced
4
reports
Battery Behavior at ERI Indication
battery, additional information, clinic, device remains, remains implanted
2
reports
Device Explanted Due to ERI Status
additional information, icd explanted, showed, explanted replaced, remains implanted
2
reports
Device Explanted for Infection
lead explanted, additional information, infection, pocket, result event
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
Evidence
Related research
Citations indexed from PubMed.
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