SQ-RX PULSE GENERATOR Adverse Events: FDA MAUDE Data
CAMERON HEALTH, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Sep 2012
Total Reports
137
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion with Explant Advised
adverse, battery, effects, technical services, services
1
reports
Subcutaneous System Explant for Unspecified Cause
implantable cardioverter, subcutaneous, subcutaneous implantable, cardioverter defibrillator, electrode
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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