RIATA ST PASSIVE FIXATION Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
1,048
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Defibrillation Impedance with Unknown Consequences
defibrillation, intervention, patient right, patient consequences, consequences
1
reports
Noise Oversensing with Programming Changes
changes, revealed, patient presented, oversensing, intervention performed
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Transvenous lead extractions in a single high-volume center over a 24-year period: High success rate and low complication rate
Thomas Morgan Knutsen, et al. · Heart Rhythm O2 · 2023
Minimal Cardiac Perforation by Lead Pacemaker Complicated with Pericardial Effusion and Impending Tamponade: Optimal Management with No Pericardiocentesis Driven by Echocardiography
Carlo Caiati, et al. · Diagnostics · 2020
Citations indexed from PubMed.
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