PERMANENT PACEMAKER ELECTRODE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
4,688
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Noisy Signals and High Impedance Measurements
noise, crt, adverse, remains service, effects
23
reports
Lead Explanted and Replaced for Unknown Reason
adverse, infection, effects, reported lead, additional adverse
8
reports
RA Lead Explanted During Infection Revision
lead explanted, infection, effects, reported lead, additional adverse
6
reports
Lead Explanted During Infection Revision
adverse, lead explanted, infection, effects, implantable
2
reports
CRT-D System Explanted Due to Infection
cardiac resynchronization, crt, infection, crt explanted, resynchronization therapy
1
reports
Ipg / Pulse Generator / Implantable Pulse
implantable pulse, pulse generator, generator ipg, oversensing, ipg
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Causes of Failure to Capture in Pacemakers and Implantable Cardioverter-defibrillators
Ebrahim Sabbagh, et al. · Journal of Innovations in Cardiac Rhythm Management · 2020
Prevalence, predictors, and prognosis of tricuspid regurgitation following permanent pacemaker implantation
Jiwon Seo, et al. · PLoS ONE · 2020
Citations indexed from PubMed.
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