Isoflex Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998 · 6 device variants grouped
Total Reports
4,067
Reports (30d)
33
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Dislodged Lead Not Used During Implant
patient stable, stable condition, patient presented, used, implant procedure
28
reports
Oversensing Episodes Resolved by Lead Replacement
resolve event, observed right, patient stable, capped replaced, oversensing
9
reports
Noise Oversensing with Programming Changes
changes, revealed, patient presented, oversensing, intervention performed
8
reports
ICD System Explant Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
8
reports
Dislodged RV Lead Confirmed by Fluoroscopy
replaced patient, atrial lead, dislodgement, leads, right atrial
7
reports
Loss of Capture and High Pacing Impedance
replaced patient, clinic, capped replaced, patient presented, presented
4
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
Late unexpected complete fracture of a right ventricular lead still capturing the myocardium
Teona Serafimova, et al. · BMJ Case Reports · 2021
Utility of a multipurpose catheter for transvenous extraction of old broken leads: A novel technique for fragile leads
Ayako Okada, et al. · Heart Rhythm · 2023
Inhibition of ventricular output in a dual chamber pacemaker with normal pacing and sensing parameters: What is the mechanism?
Debabrata Bera, et al. · Indian Pacing and Electrophysiology Journal · 2021
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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