Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit
AUDIENCE: Neurology, Nursing, Risk Manager, Surgery
ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the potential for damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.Depending on the extent of lead damage and the need to use electrode #3, lead replacement may be required or optimal therapy may not be provided.
This recall covers 1,598 devices distributed in the United States between 04/2006 and 02/28/2013. Refer to the Recall Notice for a list of affected models.
BACKGROUND: The deep brain stimulation (DBS) system delivers electrical stimulation to selected targets in the brain. DBS leads are indicated for Dystonia, Essential Tremor, Obsessive-Compulsive Disorder, Parkinson’s disease, and epilepsy. Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus or the subthalamic nucleus to aid in the management of chronic, intractable (drug refractory) primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis).
RECOMMENDATION: If the lead cap is used during the implant procedure, customers should follow modified instructions (refer to the Urgent Medical Device Correction letter for details). For questions call Medtronic Neuromodulation Technical Services 1-800-707-0933. The firm is providing additional instructions for capping the lead and removing the lead cap and is not removing the product from market. There is no action required for existing patients in the absence of concern over potential lead damage.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178