Isoflex Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998 · 6 device variants grouped
Total Reports
4,034
Reports (30d)
35
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Oversensing and High Thresholds
condition, replaced patient, patient stable, clinic, capture
30
reports
RV Lead Failed to Capture Post-Implant
procedure patient, stable, patient presented, used, implant procedure
26
reports
Infection in Device Pocket
infection, pocket, condition patient, stable, patient presented
7
reports
RV Lead Exhibited Noise Oversensing
exhibited noise, intervention, revealed, patient presented, presented
6
reports
RV Lead Fractured During Procedure
replaced patient, patient stable, patient presented, stable, remained
5
reports
Template Summary: Analysis Event
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Prevalence and management of electrical lead abnormalities in cardiac implantable electronic device leads
Hilary Roberts, et al. · Heart Rhythm O2 · 2023
Long-term performance of an atrial lead capable of accelerometer based detection of cardiac contractility in patients receiving cardiac resynchronisation therapy.
Senoner T, et al. · PloS one · 2019
Citations indexed from PubMed.
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