MEDTRONIC LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator
Total Reports
1,363
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Periprocedural Complications with BVP
bvp, stroke, higher, periprocedural complications, bundle
13
reports
High Capture Threshold with Device in Service
replaced, remains service, lead exhibited, service, device remains
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures.
Kallinen LM, et al. · Heart rhythm · 2010
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
Implant experience with unipolar polyurethane pacing leads.
Byrd CL, et al. · Pacing and clinical electrophysiology : PACE · 1983
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
Clinical routine implantation of a dual chamber pacemaker system designed for safe use with MRI: a single center, retrospective study on lead performance of Medtronic lead 5086MRI in comparison to Medtronic leads 4592-53 and 4092-58.
Wollmann CG, et al. · Herzschrittmachertherapie & Elektrophysiologie · 2011
Citations indexed from PubMed.
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