RIATA ACTIVE FIXATION Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
3,091
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Fractured Lead During Generator Change
lead capped, replaced patient, patient stable, patient presented, remained
2
reports
High Defibrillation Impedance with Unknown Consequences
defibrillation, intervention, patient right, patient consequences, consequences
2
reports
Noise Oversensing with Programming Changes
changes, revealed, patient presented, oversensing, intervention performed
2
reports
Oversensing Episodes Resolved by Lead Replacement
resolve event, observed right, patient stable, capped replaced, oversensing
2
reports
High Thresholds on Right Ventricular Lead
high capture, stable condition, thresholds, exhibited high, use right
1
reports
Lead Dislodgement with Helix Malfunction
replaced patient, patient stable, high capture, consequences, helix
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
Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker
Robert G. Hauser, et al. · Heart Rhythm · 2021
Citations indexed from PubMed.
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