Ilivia 7 VR-T DF-1 ProMRI Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024

Total Reports

120

Reports (30d)

2

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Unexpected Battery Behavior in Device

currently, battery, additional information, device remains, remains implanted

2

reports

2

ICD Explanted for ERI Status

currently, additional information, icd explanted, showed, remains implanted

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Active safety signals

Disproportionate reportinghigh

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.