MEDTRONIC ICD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator
Total Reports
374
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Fracture with Oversensing and ATP
icd, lead exhibited, service, device remains, remains
3
reports
Hospitalizations from Pacing-Induced Cardiomyopathy
hospitalizations, bvp, lbbap, bundle branch, branch
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Implementation of lead safety recommendations.
VAN Rees JB, et al. · Pacing and clinical electrophysiology : PACE · 2009
Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics
Jeanne E. Poole, et al. · Heart Rhythm · 2021
Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID Going Head to Head Trial.
Gold MR, et al. · Heart rhythm · 2011
Contemporary Implantable Cardioverter-Defibrillator Benefit
Anne B. Curtis, et al. · JACC. Clinical electrophysiology · 2025
Citations indexed from PubMed.
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