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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00124-1
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 11/02/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue The proximal end of the DBS lead can 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 #3 which could affect electrode contact #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.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is working on a corrective action to reduce the occurrence of setscrew connector block twisting. It is recommended that the lead cap is not used until corrective actions are implemented. If it is imperative that the operation be carried out in a two stage procedure users are required to follow modified instructions:

-Capping the Lead
Step 4 - Any time you use a torque wrench, hold the setscrew connector block firmly between thumb and forefinger to prevent rotation of the block
Step 5 - Tighten the single setscrew socket on the number 3 lead contact by turning it clockwise with the torque wrench provided. Tighten the setscrew until it touches the contact; then continue tightening for a maximum of 1/4 turn only (you may or may not hear the sound of a click).

-Removing the Lead Cap
Step 5 & 6 - Hold the setscrew connector block firmly between thumb and forefinger to prevent rotation. Failure to prevent rotation may break or damage the lead, and may require lead replacement.
Contact Information 1800 707 - Medtronic Neuromodulation Technical Services