CAPSUREFIX Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1996 · 9 device variants grouped
Total Reports
46,089
Reports (30d)
546
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Not Used Due to Deployment Issues
pacing lead, attempted, used replaced, attempted used, used
53
reports
Undersensing During Atrial Fibrillation Events
termination, tachycardia atrial, resulting termination, episodes resulting, fibrillation stored
34
reports
CRT-D System Explanted Due to Infection
cardiac resynchronization, crt, infection, crt explanted, resynchronization therapy
32
reports
Far Field R-Wave Oversensing Detected
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
29
reports
Ipg / Pulse / Implantable Pulse
pulse, implantable pulse, pulse generator, generator ipg, ipg
26
reports
IPG Explanted Due to Infection
implantable pulse, infection, event patient, patient developed, ipg explanted
23
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Hsieh JC, et al. · HeartRhythm case reports · 2023
A fast MR-thermometry method for quantitative assessment of temperature increase near an implanted wire
Marylène Delcey, et al. · PLoS ONE · 2021
Implantable Cardioverter-Defibrillator (ICD) Lead-Induced Septal and Left Ventricular Perforation in Hypertrophic Cardiomyopathy: A Case Report.
Alexiou P, et al. · Cureus · 2026
Late ventricular pacemaker lead perforation after electrical cardioversion—A case report
Bert Vandenberk, et al. · HeartRhythm Case Reports · 2022
An intuitive method to reduce the defibrillation threshold: a case report
Hayyan Asim Chaudry, et al. · European Heart Journal - Case Reports · 2023
Citations indexed from PubMed.
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