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
1,986
Reports (30d)
5
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
CRT-D System Explanted Due to Infection
cardiac resynchronization, crt, infection, crt explanted, resynchronization therapy
3
reports
Undersensing / Exhibited Undersensing / Tachycardia
exhibited undersensing, undersensing, tachycardia, atrial tachycardia, resulting
2
reports
Ipg / Pulse / Implantable Pulse
pulse, implantable pulse, pulse generator, generator ipg, ipg
2
reports
Far Field R-Wave Oversensing Detected
ffrw, wave ffrw, field wave, ffrw oversensing, far field
2
reports
RA Lead Capped and Replaced
lead capped, replaced, right ventricular, capped replaced, ventricular lead
2
reports
Undersensing Triggering False Termination Events
tachycardia atrial, triggering, false, atrial fibrillation, termination atrial
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker
Robert G. Hauser, et al. · Heart Rhythm · 2021
Schernthaner C, et al. · Cardiology research · 2013
MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results.
Shenthar J, et al. · Heart rhythm · 2014
Nordenswan HK, et al. · Circulation · 2022
Shahian DM, et al. · Pacing and clinical electrophysiology : PACE · 1993
Citations indexed from PubMed.
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