PLATINIUM Adverse Events: FDA MAUDE Data

MICROPORT CRM SRL · CRT-Defibrillator (CRT-D) · First cleared May 2008

Total Reports

244

Reports (30d)

0

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Inappropriate Shock Delivered by ICD

implantable cardioverter, icd, cardioverter, cardioverter defibrillator, inappropriate

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 reportingmedium

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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.