RIATA ACTIVE FIXATION Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
3,089
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Fractured During Procedure
replaced patient, patient stable, patient presented, stable, remained
2
reports
RV Lead Oversensing and High Thresholds
condition, replaced patient, patient stable, clinic, capture
2
reports
High Defibrillation Impedance Observed
impedance, defibrillation, patient right, patient consequences, consequences
1
reports
Patient Expired with Unknown Cause
implantable cardioverter, tachycardia, cardioverter defibrillator, defibrillator icd, implant procedure
1
reports
RV Lead Exhibited Noise Oversensing
exhibited noise, intervention, revealed, patient presented, presented
1
reports
RV Lead Explanted and Replaced
condition, lead capped, capped, capped replaced, explanted replaced
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design
George H. Crossley, et al. · Journal of Cardiovascular Electrophysiology · 2022
A head-to-head comparison of laser vs. powered mechanical sheaths as first choice and second line extraction tools
Előd János Zsigmond, et al. · EP Europace · 2022
Citations indexed from PubMed.
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