RA LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
195
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Low Impedance Triggering Lead Safety Switch
reflects, adverse, remains service, effects, service
5
reports
Infection Leading to RA Lead Revision
lead explanted, infection, revision, effects, additional adverse
1
reports
Lead Dislodged and Repositioned
adverse, effects, reported right, service, additional adverse
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
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