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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00617-1
Product Name/Description	Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator) Model Number: 3387 ARTG Number: 137374 Model Number: 3389 ARTG Number: 137138 Model Number: 3391 ARTG Number: 174469
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	17/06/2013
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	This is a follow up action to RC-2013-RN-00124-1. Medtronic issued an Urgent Recall for Product Correction to inform surgeons of the potential for the proximal end of the DBS lead to be damaged when the connector block of the DBS lead cap twists within the assembly when turning the set screw during step 1 of DBS surgery. The damage would most likely occur at lead contact number 3 which could affect electrode contact number 3. There is a 5.0 in-oz requirement on the lead cap assembly specification. Recent testing indicates that this requirement is not being met. Medtronic has implemented manufacturing process changes that address the twisting of the setscrew connector block within the lead cap and is now removing any unused product that was distributed to customers prior to implementing the change.
Recall Action	Recall
Recall Action Instructions	Medtronic is advising their customers that a sales representative will organise for the return of all affected stock. Surgeons are also advised that the work around instructions described in recall RC-2013-RN-00124-1 are no longer necessary for new lots of the product.
Contact Information	1800 668 670 - Medtronic Australia