Plexa ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998 · 9 device variants grouped
Total Reports
5,138
Reports (30d)
24
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted for Oversensing and Shock
received file, lead capped, inappropriate, channel, oversensing
27
reports
Lead Explanted Due to Noise
patient events, events reported, file updated, updated lead, reported additional
22
reports
Lead Capped for Noise and Fracture
additional information, file, lead capped, file updated, updated lead
19
reports
Noise on Multiple Channels
additional information, received file, file updated, channel, remains implanted
9
reports
Template Summary: Infection Update
additional information, received file, infection additional, file updated
8
reports
RV Lead Capped Due to Noise
file, patient events, events reported, updated lead, reported additional
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Clinical safety of the ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 3 T: results of the ProMRI 3T ENHANCED Master study.
Zbinden R, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2019
Vezi B, et al. · Cardiovascular journal of Africa · 2022
Adduci C, et al. · Journal of clinical medicine · 2018
Saleem M, et al. · Cureus · 2022
Remarkably high and accelerating failure rate of a widely used implantable cardioverter-defibrillator lead: A large-scale manufacturer-independent multicenter study with long accurate follow-up
Erik F.J. Oosterwerff, et al. · Heart Rhythm O2 · 2024
Citations indexed from PubMed.
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