Capsurefix DXAC/DSP Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996 · 2 device variants grouped
Total Reports
2,018
Reports (30d)
15
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Thresholds in RA Lead
thresholds lead, lead capped, lead lead, exhibited high, use right
4
reports
Undersensing During Atrial Events
progress, tachycardia atrial, resulting termination, events, atrial fibrillation
3
reports
Premature Battery Depletion in IPG
implantable pulse, right ventricular, pulse generator, generator ipg, ipg
2
reports
Far Field R-Wave Oversensing
wave ffrw, field wave, wave, ffrw oversensing, far field
2
reports
Noise and Oversensing in RA Lead
noise, exhibited oversensing, exhibited noise, use right, oversensing
2
reports
Undersensing in Both Leads
tachycardia atrial, leads remain, exhibited undersensing, undersensing resulting, undersensing
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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