TGA hazard alert for Medtronic deep brain stimulation therapy DBS Extension models 7483 and 37086

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is issuing a hazard alert for Medtronic deep brain stimulation therapy DBS Extension models 7483 and 37086. Medtronic Australasia is also undertaking a recall for product correction to update information in the device’s labelling to reduce the risks of adverse events related to the tunnelling procedure used during implantation.

Medtronic deep brain stimulation therapy DBS Extension models 7483 and 37086 are implantable, programmable medical devices that deliver electrical stimulation to the patient’s brain. These devices are used to treat the symptoms associated with movement disorders, epilepsy and Parkinson’s disease, as well as other conditions.

Additional information regarding the potential risks associated with the standard tunnelling procedure used during implantation of this device has been identified through ongoing monitoring of adverse event reports and published literature.

Updates to the device’s labelling clarifies the known potential risks, which assists health professionals with patient selection and obtaining informed consent, as well as helps to mitigate risks during implantation and post-implantation follow-up.

Please note that the likelihood of the newly identified potential adverse events occurring is very low (occurring in an estimated 0.008% of tunnelling procedures).

Information for consumers

If you or someone you provide care for has an implanted deep brain stimulator, be aware of this issue.

Please note that the likelihood of the newly identified potential adverse events occurring is very low and, if they did occur, would be experienced shortly after implantation surgery.

If you have any questions or concerns about the device, talk to your health professional.

Information for health professionals

If you are treating a patient who has a Medtronic deep brain stimulator affected by this hazard alert, be aware of this issue.

If they have any questions or concerns about this issue, refer them to their managing surgeon.

Information for surgeons

Medtronic Australasia has written to surgeons who have implanted a Medtronic deep brain stimulator affected by this hazard alert, or are managing patients who have these devices, to provide further information.

If you are managing a patient who has a Medtronic deep brain stimulator affected by this hazard alert, be aware of this issue and ensure that you are familiar with the updated labelling for this device.

The following serious adverse events related to the standard tunnelling procedure, which previously had not been included in the device’s labelling, have been identified:

• spinal accessory nerve injury
• severe bleeding or vascular injury
• an extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision
• tunnelling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removed.

During implantation, use caution while tunnelling the extension from the lead to the implanted deep brain stimulator to avoid tunnelling too deeply or superficially because serious injury may occur. Please note that complications or adverse events related to the tunnelling procedure may include injury to nerve tissue (such as the spinal accessory nerve), vascular injury that may result in prolonged hospitalisation, and tunnelling through unintended anatomy (such as in between the ribs and entering the thoracic cavity).

In the immediate post-operative period, patients should be monitored for signs and symptoms of potential complications or adverse events related to the tunnelling procedure.

If you have any questions or concerns about this issue, contact Medtronic Australasia on 1800 668 670.

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.

(Source: Australian Government – Department of Health)