RIATA ST OPTIM LEAD Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
426
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Oversensing and High Thresholds
condition, replaced patient, patient stable, clinic, capture
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Failed defibrillation with unexpected battery depletion by cable externalization of dual-coil defibrillator lead
Katsuhide Hayashi, et al. · HeartRhythm Case Reports · 2024
Long-Term Performance of the Riata/ST Implantable Cardioverter-Defibrillator Lead.
Ströker E, et al. · The American journal of cardiology · 2015
Extraction outcomes of implantable cardioverter-defibrillator leads vary by manufacturer and model family
Katsuhide Hayashi, et al. · EP Europace · 2023
Long-term performance of single-connector (DF4) implantable defibrillator leads.
Ibrahim 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 · 2023
Citations indexed from PubMed.
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