NEUTRINO NXT HF Adverse Events: FDA MAUDE Data
ABBOTT MEDICAL (CRM-SYLMAR) · CRT-Defibrillator (CRT-D)
Total Reports
149
Reports (30d)
0
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
ICD Post-Paced T-Wave Oversensing
paced wave, oversensing pptwos, cardioverter defibrillator, defibrillator icd, icd exhibited
11
reports
Remote Follow-Up Oversensing Observed
observed device, remote follow, stable continue, recommended reprogramming, technical support
10
reports
Remote Monitoring Post-Paced Oversensing
net, remotely merlin, net review, merlin net, presented remotely
9
reports
In-Clinic Post-Paced T-Wave Oversensing
observed device, support contacted, patient stable, technical support, pptwos
8
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
4
reports
ICD Delivered Inappropriate Shock
implantable cardioverter, icd, patient implantable, cardioverter defibrillator, defibrillator icd
4
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
Kowal D, et al. · Journal of cardiovascular development and disease · 2023
Boles U, et al. · Indian pacing and electrophysiology journal · 2017
Masoudi FA, et al. · Circulation. Cardiovascular quality and outcomes · 2012
Varma N, 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 · 2023
Citations indexed from PubMed.
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