EXCELLENCE+ Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Jan 2019
Total Reports
146
Reports (30d)
2
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Dual-Lead Noise with Generator Electromagnetic Interference
noise, implantable pulse, pulse generator, generator ipg, ipg
2
reports
Ventricular Undersensing Causing Inappropriate Pacing
pacing lead, exhibited undersensing, undersensing, use right, resulting
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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