MEDTRONIC LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator
Total Reports
1,571
Reports (30d)
4
Active Signals
0
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
21
reports
Hospitalizations from Pacing-Induced Cardiomyopathy
hospitalizations, bvp, lbbap, bundle branch, branch
14
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Transvenous lead extraction of lumenless 3830 pacing lead in conduction system pacing: a single-center experience
Federico Migliore, et al. · Journal of Interventional Cardiac Electrophysiology · 2023
Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures.
Kallinen LM, et al. · Heart rhythm · 2010
Implant experience with unipolar polyurethane pacing leads.
Byrd CL, et al. · Pacing and clinical electrophysiology : PACE · 1983
Towards eradication of inappropriate therapies for ICD lead failure by combining comprehensive remote monitoring and lead noise alerts.
Ploux S, et al. · Journal of cardiovascular electrophysiology · 2018
A Novel Quadripolar Active Fixation Left-Ventricular Pacing Lead for Cardiac Resynchronization Therapy: Initial United Kingdom Experience.
Chapman M, et al. · JACC. Clinical electrophysiology · 2019
Citations indexed from PubMed.
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