NEUTRINO NXT HF Adverse Events: FDA MAUDE Data
ABBOTT MEDICAL (CRM-SYLMAR) · CRT-Defibrillator (CRT-D) · First cleared May 2024
Total Reports
224
Reports (30d)
33
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Paced T-Wave Oversensing with Unknown Status
icd, implantable cardioverter, cardioverter, patient implantable, cardioverter defibrillator
10
reports
LV Lead Dislodgement with Phrenic Stimulation
left, left ventricular, patient presented, presented, ventricular lead
8
reports
Remote Post-Paced Oversensing Under Monitoring
observed device, remote follow, support contacted, technical support, device technical
5
reports
Remote Oversensing with Reprogramming Recommended
remote follow, support contacted, technical support, contacted recommended, device technical
5
reports
Remote Transmission Post-Paced T-Wave Oversensing
merlin net, revealed, presented remotely, patient presented, remotely merlin
4
reports
Remote Oversensing Pending Reprogramming
observed device, support contacted, technical support, contacted recommended, device technical
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Early Smartphone App-Based Remote Diagnosis of Silent Atrial Fibrillation and Ventricular Fibrillation in a Patient with Cardiac Resynchronization Therapy Defibrillator
Dagmar Kowal, et al. · Journal of Cardiovascular Development and Disease · 2023
Smartphone App-Based Remote Monitoring Challenges in Patients with Cardiac Resynchronization Therapy Defibrillators—A Multicenter Study
Dagmar Kowal, et al. · Journal of Clinical Medicine · 2024
Citations indexed from PubMed.
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