Inquest into the death of Kerryn Foale
Deceased
Kerryn Foale
Demographics
22y, female
Date of death
2011-06-05
Finding date
2015-09-26
Cause of death
ventricular fibrillation resulting from hypertrophic cardiomyopathy when her implantable cardioverter defibrillator failed to terminate the arrhythmia and convert it to normal heart rhythm due to a short circuit in the lead caused by abrasion damage
AI-generated summary
22-year-old woman with hypertrophic cardiomyopathy died from ventricular fibrillation when her implantable cardioverter defibrillator (ICD) failed to terminate the arrhythmia due to lead insulation failure caused by chronic abrasion. The St Jude Riata 1570 lead had been implanted 8 years prior and was subject to manufacturer warnings about potential insulation defects. Clinical lessons include: leads are vulnerable to mechanical stress over time despite best design efforts; manufacturers issued warnings but clinicians faced dilemmas balancing risks of lead replacement against risks of leaving potentially failing leads in situ; there was no way for clinicians to detect progressive insulation damage without painful testing or device interrogation; modern ICDs now have automated self-testing capacity. The coroner found no criticism of the treating doctors' care, which was highly professional. Key preventive opportunities would be mandatory device failure reporting, national device registries, and guidelines for testing older leads.
AI-generated summary and tagging — may contain inaccuracies; refer to original finding for legal purposes.
Specialties
Error types
Clinical conditions
Procedures
Contributing factors
- lead insulation failure from chronic mechanical abrasion over 8 years of implantation
- inability to detect progressive lead deterioration without painful testing
- short circuit in high voltage lead causing shock to be shunted away from heart
- likely secondary damage to ICD internal circuitry rendering further shocks ineffective
- lack of mandatory reporting system for device failures
- absence of automated self-testing capacity in older ICD models
- absence of national registry for implanted cardiac devices
Coroner's recommendations
- Consideration be given to establishing a national registry of implanted cardiac devices that would capture full details of the cardiac device (brand/model) and details of the patient in whom such device was implanted
- Consideration be given, in consultation with the Cardiac Society of Australia and New Zealand and manufacturers, to requiring mandatory reporting of failures of or significant incidents concerning implanted cardiac devices by clinicians, allied health professionals, and device manufacturers or their Australian agents
- The Cardiac Society of Australia and New Zealand consider developing guidelines concerning the regular testing of implanted cardiac devices that do not have in-built, regular, painless, circuitry-testing capacity
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