PLATINIUM Adverse Events: FDA MAUDE Data
MICROPORT CRM SRL · CRT-Defibrillator (CRT-D) · First cleared Jul 2016 · 3 device variants grouped
Total Reports
250
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Unable to be Interrogated
implantable cardioverter, icd, patient implantable, cardioverter defibrillator, defibrillator icd
1
reports
RV Lead Oversensing and Pacing Inhibition
defibrillator crt, crt, lead, use, high
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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