Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit / Recall/ USA

Recall Class: Class I

Date Recall Initiated: February 08, 2013

Product: Medtronic Deep Brain Stimulation Lead Kits:
Models 3387, 3387S, 3389, 3389S, 3391, 3391S

Dystonia HDE Therapy Kits:
Models 3317, 3319, 3337, 3339

This recall covers 1,598 devices distributed in the United States between 04/2006 and 02/28/2013.

Use: 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).

Recalling Firm:
Medtronic Neuromodulation
7000 Central Ave. NE
Minneapolis, Minnesota, 55432-3568

Reason for Recall: There is a 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.

Public Contact: Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

FDA District: Minneapolis

FDA Comments:
Medtronic sent an Urgent Medical Device Correction letter  dated February 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to follow modified instructions if the lead cap is used during the implant procedure. 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.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Fonte: FDA.