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Health professionals and consumers are advised that sponsor, Sorin Group Australia, in consultation with the TGA, has issued a hazard alert for Isoline defibrillation leads.
Isoline defibrillation leads are used in implantable cardioverter-defibrillator (ICD) devices for patients with certain heart conditions.
The sponsor is warning that a potential problem with the leads' insulation may cause the device to malfunction.
This warning affects two models of Isoline defibrillation leads:
- 2CR6
- 2CT6
Sorin Group Australia has advised that no permanent serious injury or death has been reported as a result of the above fault.
Only 40 units were implanted in Australia between 1 June 2006 and 31 August 2011. Those patients were managed by nine doctors, based in seven hospitals in NSW, Victoria and Tasmania. The sponsor has written to the doctors/hospitals who implanted Isoline defibrillation leads, advising them of this issue.
Sorin Group Australia advises that, as of 31 December 2012, of the 13,500 units implanted worldwide, 30 units have been found to have the fault.
Information for consumers
Patients who were implanted with an ICD in Australia should have been given a patient identification card by their implanting surgeon. The card lists the model number of their device and details of the leads used.
For Isoline defibrillation leads, the patient ID card lists the internal model number rather than an item description. The internal model numbers for the two models are:
- Isoline 2CR6-IJ247
- Isoline 2CT6-IJ237
If you have an ICD that uses these Isoline defibrillation leads, or any general questions or concerns about your ICD, contact your cardiologist.
Information for all health professionals
Patients with any issues that may involve an ICD should be referred to a cardiologist, preferably the implanting cardiologist.
Information for cardiologists
Cardiologists who have implanted an ICD that uses Isoline defibrillation leads should have received written advice from Sorin Group Australia and are advised to review that information closely. The sponsor is warning that a potential breach in the leads' internal insulation may cause the device to malfunction.
Sorin Group Australia has advised that, in each of the 30 identified cases, the internal insulation breach was under the right ventricular and/or Superior Vena Cava defibrillation coil, where the microcables are not coated with ethylene tetrafluoroethylene. This resulted in contact between the conductors, thus leading to low pacing impedance, and/or ventricular oversensing, and/or inappropriate therapies. Please note that, in the case of ventricular oversensing, pacing is inhibited.
Considering the low occurrence rate of the above fault, replacement or removal of Isoline defibrillation leads is not recommended if no malfunction is detected.
Cardiologists should continue to regularly monitor their patients who have an ICD that uses Isoline defibrillation leads. In the absence of any evidence of malfunction, standard follow-up processes, as recommended in the written advice from Sorin Group Australia, apply.
If cardiologists have any questions or concerns, they should contact their local Sorin Group Australia representative or call 1800 452 650.
Additional information
It should be noted that Isoline defibrillation leads were cancelled from the Australian Register of Therapeutic Goods (ARTG) in November 2011 after manufacturing issues identified by the TGA, unrelated to this safety advisory, were not resolved.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.