—#114756

Product

Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: Kinetra Model 7428 or Soletra Model 7426 Neurostimulator Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: Soletra Model 7426 Neurostimulator Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension Model 3387 or Model 3389 Lead.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009S007, P960009S051, P960009S134
Affected lot / code info: NHU236350V to NHU236373V; NKN037257V to NKN037259V; NKN037372V to NKN037387V; NKN037476V to NKN037507V; NKN037692V to NKN037698V; NKN037772V to NKN037779V; NKN037790V to NKN037810V; NKN037812V to NKN037840V.

Why it was recalled

Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medtronic beginning November 15, 2012 , initiated a retrieval of unused inventory in the field. In the US, three customers were identified. Medtronic field representatives visited these US accounts to facilitate product identification and removal. If product was removed a letter was provided to the facility describing the recall. The letter dated November 2012, "Medtronic Medical Device recall" was addressed to the Hospital. Beginning on December 3, 2012, Medtronic mailed healthcare professional letters to physician who have used the affected product. The Medtronic " Medical Device Recall" letter was dated November 2012. The letter identified the problem, the product involved in the recall, and provided advise if the product was used. A reply card was provided to each physician to confirm they have received and understood the communication. For further questions please call (763) 514-2000.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) including the states of CT, MI, NH, NY, OH, PA and VT., and the countries of AUSTRALIA, JAPAN, BELGIUM, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.

Timeline

Recall initiated: 2012-12-03
Posted by FDA: 2012-12-19
Terminated: 2013-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.