—#73448

Product

Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy 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. Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009
Affected lot / code info: PIN # 3387028103, 3387040103, and 338704004V

Why it was recalled

Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d

Root cause (FDA determination)

Process design

Action the firm took

Consignees were sent a "Medtronic Urgent: Medical Device Correction" letter 8/2008. The letter addressed to Healthcare Professionals, described the product involved, explanation of the issue, recommendations for Implant and included an attachment "Updated Instructions for Using the Lead Cap". Contact Medtronic Neuromodulation at 1-800-707-0933 for assistance.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: AL, AZ, AR, CA, CO, CT, FL, DC, GA, HI, ID, IL , IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE , NV, NH, NJ, NM, NY, NC, ND, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI. ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROATIA, CYPRESS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, LUXEMBOURG, MEXICO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Timeline

Recall initiated: 2008-06-14
Posted by FDA: 2008-10-27
Terminated: 2011-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73448. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.