Optisure dual coil defibrillation leads

Hazard alert - potential for loss of therapy due to lead insulation damage

12 November 2015

Consumers and health professionals are advised that St Jude Medical, in consultation with the TGA, has issued a hazard alert for a small number of Optisure dual coil defibrillation leads. St Jude Medical has already recalled the two unused potentially affected leads that were on hospital shelves in Australia.

Optisure dual coil defibrillation leads are used with implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRTD) devices to treat abnormal heart rhythms and improve the heart’s blood pumping ability.

It has been identified that a small number of Optisure dual coil defibrillation leads may have been compromised during the manufacturing process, resulting in insulation damage.

St Jude Medical has confirmed that all potentially affected leads supplied in Australia are connected to devices that have Dynamic Tx technology.

If enabled, Dynamic Tx technology will automatically change the shock configuration to continue high voltage therapy if a short circuit occurs.

However, if an affected lead is being used with a device that does not have Dynamic Tx technology enabled, the patient could experience loss of defibrillation therapy due to a short circuit.

The likelihood of the above problem occurring is very low and there have been no reported cases worldwide.

This potential problem only affects a small number of Optisure dual coil defibrillation leads implanted in Australia, which have the following serial numbers:

  • BRG010030
  • BRG010049
  • BRG010050
  • BRG010051
  • BRG010087
  • BRG010177
  • BRG010421
  • BRG010624
  • BRG010648
  • BRG010654
  • BRG010679
  • BRG010693
  • BRG011022
  • BRG011478
  • BRH010632
  • BRH011475
  • BRP010075
  • BRP010076
  • BRP010077

Information for consumers

If you or someone you care for has an ICD or CRTD implanted, and you have any questions or concerns about this issue, contact your health professional.

Please note that this potential problem only affects a small number of Optisure dual coil defibrillation leads and the likelihood of you experiencing this issue is very low.

If you have a potentially affected device, your cardiologist will assess it at your next follow-up visit.

Information for all health professionals

If you are treating someone who has an ICD or CRTD that is connected to one of the 19 Optisure dual coil defibrillation leads listed above, advise them of this issue.

Reassure them that this potential problem only affects a small number of Optisure dual coil defibrillation leads and the likelihood of them experiencing this issue is very low. Their cardiologist will assess the device at their next follow-up visit.

If they continue to have questions or concerns about this issue, refer them to their cardiologist or the hospital where the surgery was performed.

Information for cardiologists

St Jude Medical has written to cardiologists who have implanted or are managing the follow-up of the 19 patients with a potentially affected Optisure dual coil defibrillation lead to advise them of this issue and to provide information regarding patient management.

Advise patients who have an ICD/CRTD that is connected to one of the 19 potentially affected Optisure dual coil defibrillation leads of this issue. Reassure them that this potential problem only affects a small number of leads and the likelihood of them experiencing this issue is very low.

At an affected patient's next follow-up visit, it is recommended that you:

  1. review their records
  2. ensure DynamicTx is programmed 'On'
  3. enrol them in Merlin.net, if available (as long as you or the hospital has a Merlin.net account, St. Jude Medical will provide the patient a Merlin@home monitor free of charge and enter them in the system immediately)
  4. monitor them as normal - no additional testing or follow-up is needed.

It is also recommended that a St Jude Medical representative be present at their next follow-up visit to program an alert message in the implanted device.

If you have any questions or concerns about this issue, contact St Jude Medical on 02 9936 1200.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. 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.