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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