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
1,963
Reports (30d)
28
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Undersensing During AF Events
termination, tachycardia atrial, exhibited undersensing, events, impedance
4
reports
High Thresholds Leading to Lead Replacement
thresholds lead, lead explanted, event right, replaced patient, thresholds
3
reports
Far Field R-Wave Oversensing
exhibited far, wave ffrw, field wave, ffrw oversensing, far field
2
reports
Fractured Leads Replaced with Leadless IPG
implantable pulse, leadless, pulse generator, generator ipg, ipg
2
reports
Undersensing on EGM in Ventricular Lead
undersensing stored, right ventricular, electrograms egm, egm, ventricular lead
2
reports
False Termination of Atrial Events
termination, tachycardia atrial, triggering, false, atrial fibrillation
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
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