RIATA ACTIVE FIXATION Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
1,922
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted for Under-Sensing
revision, dislodgement, leads, reported lead, explanted replaced
1
reports
Oversensing Observed with Stable Patient
condition, observed right, patient stable, oversensing, intervention performed
1
reports
Remote Monitoring Noise Oversensing
observed right, patient stable, continue monitored, remote, intervention performed
1
reports
Right Ventricular Lead Impedance Issue
noted right, sensing, intervention, wave, patient consequences
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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