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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