Autogen DR Implantable Cardioverter Defibrillator and Autogen Cardiac Resynchronisation Therapy Defibrillator

Consumers and health professionals are advised that Boston Scientific, in consultation with the TGA, has issued a hazard alert regarding Autogen DR Implantable Cardioverter Defibrillators (ICDs) and Autogen Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds). An issue has been identified in which these models may temporarily malfunction if one type of automated test mode is enabled. Boston Scientific is also undertaking a recall for product correction to update software.

ICDs are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. CRT-Ds are ICDs that also coordinate the beating of the left and right ventricles to improve the heart's blood pumping ability.

This issue only has the potential to affect a sub-group of patients who have devices in which the Right Ventricular Automatic Threshold (RVAT) mode is enabled. For patients with devices in which the RVAT mode is enabled, Boston Scientific has advised cardiologists to disable the affected automated test mode and perform the test manually when the patient is in-clinic.

Boston Scientific has received no reports of injury worldwide due this issue, but one patient overseas has reported experiencing brief periods of dizziness.

Boston Scientific is developing a software solution to prevent this issue and this will be implemented via a non-invasive download from the programmer when the patient is in the clinic.

The model numbers affected by this issue are:

• Autogen CRT-D
  • G172
  • G173
  • G175
  • G177
  • G179
• Autogen DR ICD
  • D046
  • D047
  • D176
  • D177

Information for consumers

Boston Scientific has contacted cardiologists treating patients with Autogen CRT-Ds or Autogen DR ICDs, providing more information about the above issue.

The problem only has the potential to occur if the RVAT mode is enabled.

If you or someone you care for has one of the affected models implanted, you should contact the treating cardiologist to see if the pacemaker has the RVAT mode enabled. If the RVAT mode is enabled the cardiologist will arrange an appointment to disable this mode and/or to upgrade the software.

If a patient experiences dizziness seek medical attention as soon as possible.

If you have any questions or concerns about this issue you should discuss them with the treating cardiologist.

Information for health professionals

If you are treating a patient who has an Autogen CRT-D or Autogen DR ICD, and they are concerned about the above issue, you should reassure them that risk of this issue occurring and any injury is low. The issue has not resulted in any reported harm to a patient.

Patients with an affected device should be advised to contact their cardiologist as soon as possible to ascertain if the RVAT mode is enabled and, if so, to schedule a consultation to ensure the affected test mode is disabled and/or to upgrade their device's software.

Information for cardiologists

Boston Scientific has written to cardiologists who are treating patients with Autogen DR ICDs and Autogen CRT-Ds providing further information about this issue, including advice regarding patient management and detailed instructions in how to disable the affected automated test mode.

Autogen DR ICDs and Autogen CRT-Ds include the option of enabling a RVAT test to determine the RV pacing threshold and adjust amplitude in an ambulatory setting. The issue arises if the RVAT test feature is enabled and noise signals are continuously sensed within a brief RV noise window following an atrial pace, a patient may not receive effective pacing support until the RVAT test ends (i.e., up to 20 cardiac cycles). There is no additional risk for patients in whom the RVAT feature is disabled.

Until a software solution can be implemented, Boston Scientific recommends that the RVAT test feature is not enabled in Autogen DR ICDs and Autogen CRT-Ds for daily automated RVAT tests, due to the potential risk of asystole occurring during the RVAT test. If the ambulatory RVAT test feature has been enabled, Boston Scientific recommends disabling the RVAT feature at the first opportunity, but within three months.

For in-clinic/commanded RVAT tests, Boston Scientific recommends that cardiologists test thresholds manually, rather than utilising the automatic RVAT test.

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.