Optisure Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead) · First cleared Feb 2014 · 33 device variants grouped
Total Reports
5,052
Reports (30d)
48
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
ICD System Explant Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
17
reports
High Pacing Impedance Capped and Replaced
replaced patient, pacing impedance, patient stable, high pacing, capped replaced
11
reports
Lead Dislodgement with Helix Malfunction
replaced patient, patient stable, high capture, consequences, helix
11
reports
Oversensing Episodes Resolved by Lead Replacement
resolve event, observed right, patient stable, capped replaced, oversensing
10
reports
Noise Oversensing with Programming Changes
changes, revealed, patient presented, oversensing, intervention performed
8
reports
Helix Malfunction During Lead Implant
lead implanted, used, new lead, implant procedure, helix
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study
Lorenzo Braghieri, et al. · Heart Rhythm · 2024
MRI Safety for Patients Implanted With the MRI Ready ICD System: MRI Ready Study Results.
Nazarian S, et al. · JACC. Clinical electrophysiology · 2019
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
Defibrillation failure with short ICD charge time: Internal short circuit of a Durata lead.
Okada A, et al. · Journal of cardiology cases · 2019
Citations indexed from PubMed.
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