PERMANENT DEFIBRILLATOR ELECTRODES Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead)
Total Reports
2,285
Reports (30d)
9
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Pace Impedance Measurements Observed
remains service, effects, received fda, technical services, fda form
6
reports
High Shock Impedance Measurement
measurements, shock, remains service, shock impedance, ohms
6
reports
Lead Capped for Performance Issue
lead capped, received fda, form, service, fda form
5
reports
Right Ventricular Lead Revision for Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
2
reports
Inappropriate ATP Delivery from Oversensing
effects, services, tachycardia, inappropriate, oversensing
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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