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
What the reports describe · Claripulse analysis
Most commonly reported problems
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.
Detection
Active safety signals
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