Consumers and health professionals are advised that Sorin Group Australia has undertaken additional software improvements to address the issues identified in the previous statement (see below). This action is being undertaken as the previous software update resulted in greater than expected variability in battery characteristics.
The new software version SmartView 2.54 is now available for implementation and improves the accuracy of the estimated residual longevity calculated by Orchestra and Orchestra Plus programming devices during a follow-up exam of affected patients.
This issue affects patients with the following pacemaker models:
- Reply DR, SR
- Esprit DR, SR
- Kora 100 DR, SR
- Kora 250 DR, SR.
The information for consumers and other health professionals provided in the below statement remains correct and appropriate. However the information for cardiologists has been updated.
Sorin Group Australia has sent new information to cardiologists in a letter dated 29 September 2016, which includes updated patient management recommendations. If you are a cardiologist managing a patient who has a potentially affected pacemaker, refer to the updated recommendations in Sorin Group Australia's letter or contact them on 1800 452 650 for further information.
If you or someone you provide care for has a pacemaker and you have any questions or concerns about this issue, talk to your health professional.
Hazard alert - risk of incorrect scheduling of follow-up examinations
29 November 2013
Health professionals are advised that Sorin Group Australia, in consultation with the TGA, has issued a hazard alert to applicable cardiologists and hospitals regarding a potential problem when Orchestra and Orchestra Plus programming devices are used with Reply and Esprit pacemakers.
Orchestra and Orchestra Plus programming devices are used by health professionals to monitor the performance and adjust the settings of pacemakers. Reply and Esprit pacemakers are implantable medical devices used to treat bradycardia. These devices provide pacing to help coordinate the heart’s pumping action and improve blood flow.
It has been identified that, when used with Reply and Esprit pacemakers during a routine follow-up examination at a hospital or clinic, Orchestra and Orchestra Plus programming devices (with software versions prior to SmartView 2.40) may display incorrect information regarding the pacemaker’s residual longevity. Specifically, the programming device may overestimate the time until the pacemaker should be replaced.
If this occurs, follow-up dates for the affected patient may not be adjusted properly and there is a risk that the time for replacement for the pacemaker could be reached between follow-up examinations.
The overall longevity of Reply and Esprit pacemakers is not affected by this issue. Depending on programmed settings and patient conditions, the expected longevity of Reply and Esprit pacemakers is normally up to 10 years. These pacemakers first became available in Australia in 2008 and should not be approaching the time for replacement.
As of 15 October 2013, no reports of serious injury or death have been reported as a result of this issue in Australia or internationally.
This issue does not affect any other Sorin pacemakers available in Australia. The affected models in Australia are:
- Reply DR dual chamber pacemaker
- Reply SR single chamber pacemaker
- Esprit DR dual chamber pacemaker
- Esprit SR single chamber pacemaker.
Sorin Group Australia is upgrading the software of Orchestra and Orchestra Plus programming devices to correct this issue.
Information for all health professionals
If you are treating a patient who is concerned about this issue, you should reassure them that it is unlikely that they will experience any problems as a result of this issue.
Patients who have had a pacemaker implanted and who continue to have questions or concerns about this issue should be referred to their cardiologist or the hospital where the procedure was performed.
Information for cardiologists
Sorin Group Australia has provided new information to cardiologists in a letter dated 29 September 2016, which includes updated patient management recommendations.
If you are managing a patient who has a potentially affected pacemaker, refer to the updated recommendations in Sorin Group Australia's letter or contact them on 1800 452 650 for further information.
Information for consumers
There is no identified problem with Reply or Esprit pacemakers and it is unlikely that patients who have been implanted with a Reply or Esprit pacemaker will experience any problems as a result of this issue.
Sorin Group Australia has written to cardiologists who are managing patients implanted with a Reply or Esprit pacemaker providing further information, and will upgrade the software of Orchestra and Orchestra Plus programming devices to correct this problem.
If you have had a pacemaker implanted and have any questions or concerns about this issue, please contact your general practitioner, cardiologist or the hospital where the procedure was performed.
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.