RV LEAD Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
188
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Shock Impedance Measurement
measurements, shock, remains service, shock impedance, ohms
3
reports
ICD Oversensing Causing ATP Delivery
implantable cardioverter, icd, cardioverter, services, cardioverter defibrillator
1
reports
Lead Capped for Performance Issue
lead capped, received fda, form, service, fda form
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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