Myopore Sutureless Myocardial Pacing Lead Adverse Events: FDA MAUDE Data
Greatbatch Ltd · Permanent Pacemaker Electrode (Lead) · First cleared Oct 2018
Total Reports
368
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted After Reprogramming
lead explanted, lead capped, reprogrammed, reported lead, used
6
reports
Lead Explanted Due to Infection
reflects, adverse, effects, additional adverse, form notification
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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