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Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation… recallZ-0184-2009 · Medtronic Neuromodulation · initiated Jun 14, 2008

Terminated All recalls posted in October 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number
Z-0184-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 14, 2008
Posted by the FDA
Oct 27, 2008
Recalling firm
Medtronic Neuromodulation
Quantity
8289
Product code
MHY
FDA submissions
P960009
Distribution
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.

Product description

Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145 Implant manual: 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.

Code information (models, lots, serial numbers)

PIN # 3387S0000V

Other devices under the same FDA submission

90 devices cleared under P960009 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 49446).

Sources and updates

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