ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead)
Total Reports
309
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Remote Monitoring Noise Oversensing
patient condition, condition, intervention, revealed, patient presented
3
reports
Noise Oversensing During Remote Follow-Up
continue, observed right, patient stable, remote, monitored
2
reports
Impedance Issue with No Intervention
noted right, intervention, low, patient consequences, consequences
2
reports
Template Summary: Event Analysis
1
reports
Oversensing Noise with No Intervention
oversensing noise, patient stable, intervention, consequences, intervention performed
1
reports
Failed Implant Attempt Due to Helix Issue
lead implanted, stable, new lead, implant procedure, helix
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Defibrillation failure with an electrical short circuit caused by internal insulation breach.
Tsurugi T, et al. · 2021
Long-Term Performance of the Riata/ST Implantable Cardioverter-Defibrillator Lead.
Ströker E, et al. · 2015
Failed defibrillation with unexpected battery depletion by cable externalization of dual-coil defibrillator lead.
Hayashi K, et al. · 2024
Extraction outcomes of implantable cardioverter-defibrillator leads vary by manufacturer and model family.
Hayashi K, et al. · 2023
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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