ELLIPSE VR ICD, US Adverse Events: FDA MAUDE Data
ABBOTT MEDICAL (CRM-SYLMAR) · Implantable Cardioverter Defibrillator (ICD)
Total Reports
116
Reports (30d)
23
Active Signals
4
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Reprogrammed After MRI Backup Mode
reprogrammed, high voltage, stable, contacted, technical
12
reports
Post-Paced T-Wave Oversensing Detected
reprogramming, stable, oversensing, contacted, technical
8
reports
ICD Backup Mode Post-MRI Scan
measurements, implantable cardioverter, high range, cardioverter defibrillator, defibrillator icd
7
reports
Noise Oversensing Detected Remotely
noise, programming, lead exhibited, defibrillator icd, stable
3
reports
Device Explanted Due to ERI Status
observed, replacement, normal, showed, stable
2
reports
Noise Oversensing on RV Lead Channel
implantable cardioverter, atrial, remains service, cardioverter defibrillator, service
2
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
Citations indexed from PubMed.
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