Optisure Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead) · First cleared May 1996 · 34 device variants grouped
Total Reports
5,004
Reports (30d)
52
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
44
reports
Infection in Device Pocket
infection, pocket, condition patient, stable, patient presented
9
reports
RV Lead Exhibited Noise Oversensing
exhibited noise, intervention, revealed, patient presented, presented
9
reports
Helix Damage During Implant Procedure
lead implanted, patient stable, used, implant procedure, helix
7
reports
Remote Monitoring Noise Oversensing
observed right, patient stable, continue monitored, remote, intervention performed
7
reports
RV Lead Failed to Capture Post-Implant
procedure patient, stable, patient presented, used, implant procedure
4
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
Comparing complication rates between Abbott Tendril 2088 and competitive manufacturer leads: Novel real‐world data approach
Aamir Ahmed, et al. · Journal of Cardiovascular Electrophysiology · 2024
Citations indexed from PubMed.
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