Myopore Sutureless Myocardial Pacing Lead Adverse Events: FDA MAUDE Data
Greatbatch Ltd · Permanent Pacemaker Electrode (Lead) · First cleared Oct 2018
Total Reports
377
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted and Replaced for Unknown Reason
adverse, infection, effects, reported lead, additional adverse
9
reports
Lead Explanted During Infection Revision
adverse, lead explanted, infection, effects, implantable
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
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
Frontiers in Cardiovascular Medicine · 2022
Citations indexed from PubMed.
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