SQ-RX PULSE GENERATOR Adverse Events: FDA MAUDE Data
CAMERON HEALTH, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Sep 2012
Total Reports
314
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Unable to Be Interrogated
clinic, stable, device remains, remains implanted, technical
1
reports
ICD Explanted for Performance Anomaly
implantable cardioverter, subcutaneous, subcutaneous implantable, cardioverter defibrillator, defibrillator icd
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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