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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00704-1
Product Name/Description Medtronic Deep Brain Stimulation (DBS) Extension Models 7483 and 37086

ARTG Number: 239412
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 6/06/2016
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has identified the following serious events or injuries associated with tunnelling that are not presented in the current DBS labelling. The following events are associated with the DBS implant and tunnelling the extension from the lead to the INS:

- Cases of spinal accessory nerve injury
- Severe bleeding or vascular injury
- An extension inadvertently implanted through the ribs and was 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

These events occurred in an estimated 0.008% of tunnelling procedures.
Recall Action Hazard Alert
Recall Action Instructions Medtronic is sharing this information to help surgeons with the DBS implant procedure, patient selection, informed consent, and post-implant follow- up for patients treated with DBS Therapy. Surgeons are advised that during the DBS implant, use caution while tunnelling the extension from the lead to the INS to avoid tunnelling too deeply or superficially because serious injury may occur. In the immediate post-operative period, surgeons are advised to monitor patients for signs and symptoms of potential complications or adverse effects related to the tunnelling procedure. Information will be added to Medtronic's Deep Brain Stimulation (DBS) labelling. For more details, please see . This action has been closed-out on 20/01/2017.
Contact Information 02 9857 9000 - Medtronic