Myopore Sutureless Myocardial Pacing Lead Adverse Events: FDA MAUDE Data
Greatbatch Ltd · Permanent Pacemaker Electrode (Lead) · First cleared Oct 2018 · 3 device variants grouped
Total Reports
742
Reports (30d)
9
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped and Replaced
lead capped, impedance, lead reprogrammed, reported lead, explanted
15
reports
System Revision Due to Infection
adverse, infection, revision, effects, implantable
2
reports
Low Pacing Impedance in RA Lead
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
1
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
Minimally invasive implantation of the myopore sutureless myocardial pacing lead.
Ceresa F, et al. · Innovations (Philadelphia, Pa.) · 2012
Thoracoscopic Implantation of Epicardial Left Ventricular Lead for Cardiac Resynchronization Therapy
Hye Ree Kim, et al. · Journal of Cardiovascular Development and Disease · 2022
Combined procedure involving thoracoscopic implantation of the epicardial left ventricular lead and removal of the His bundle pacing lead in a patient with heart failure
Jarosław Bis, et al. · Kardiologia Polska · 2020
Citations indexed from PubMed.
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