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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00847-1
Product Name/Description	Medtronic DBS Pocket Adaptor for use with Activa PC (Model 37601) and Activa RC (Model 37612) brain neuro-stimulators Model Numbers: 64001 and 64002 ARTG Number: 165114
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	13/07/2016
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	It has been identified that 16 Medtronic Neuromodulation DBS system pocket adaptors (0.08% reported rate of occurrence) have been identified with high impedance, resulting in decreased current being conducted through the device. Some of the reported cases involved loss of therapy, return of symptoms, rebound effects and potential revision surgery to replace the device. There have been no incidents reported in Australia. Analysis of the returned devices found the cause of the high impedance to be conductor wire fractures near where the wire exits the neurostimulator connector block. In two cases, the issue was identified during implantation surgery, while the other 14 were identified after implantation and resulted in revision surgery.
Recall Action	Hazard Alert
Recall Action Instructions	Medtronic is reminding users of the device labelling specific to the handling of pocket adaptors and system integrity checking during implant procedures. This action has been closed-out on 03/03/2017.
Contact Information	02 9857 9000 - Medtronic