PERMANENT DEFIBRILLATOR ELECTRODES Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead)
Total Reports
2,314
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Gradual Rise in Shock Impedance
impedance measurements, measurements, remains service, shock impedance, ohms
4
reports
High Pacing Impedance Measurements
measurements, pacing, impedance, remains service, service
3
reports
Lead Capped for Performance Issue
lead capped, product performance, service, service adverse, additional adverse
3
reports
Oversensing Due to EMI from Scalpel
icd, technical services, services, defibrillator icd, implantable
1
reports
CRT Lead High Shock Impedance Alert
resynchronization, cardiac resynchronization, crt, therapy, service
1
reports
RV Lead Capped Due to Noise
file, patient events, events reported, updated lead, reported additional
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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