{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "73448",
      "product_res_number": "Z-0186-2009",
      "event_date_initiated": "2008-06-14",
      "event_date_posted": "2008-10-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-31",
      "res_event_number": "49446",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009"
      ],
      "product_description": "Medtronic DBS\" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. \n\nMedtronic 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_info": "PIN # 3387028103, 3387040103, and 338704004V",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "800 53rd Ave NE",
      "address_2": "PO Box 1250",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55440-1250",
      "additional_info_contact": "763-514-5174",
      "reason_for_recall": "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_description": "Process design",
      "action": "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.",
      "product_quantity": "3939",
      "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.\n\nALGERIA, 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.",
      "openfda": {
        "pma_number": [
          "P960009",
          "P140009"
        ],
        "registration_number": [
          "3003120897",
          "3015924373",
          "3006630150",
          "9616693",
          "3038429246",
          "3018094310",
          "2024311",
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          "2133641",
          "2135338",
          "2124215",
          "3005210579",
          "1627487",
          "3003335547",
          "3010086866",
          "3009380063",
          "3010972758",
          "2133772",
          "3003477135",
          "3010531069",
          "2182207",
          "3015200795",
          "3006705815",
          "2183744",
          "2649622",
          "3010052483",
          "3019807891",
          "2648729",
          "3013023969",
          "3004593495",
          "1928237",
          "3004209178"
        ],
        "fei_number": [
          "3003120897",
          "3015924373",
          "3006630150",
          "3038429246",
          "3018094310",
          "2024311",
          "3005160949",
          "2124215",
          "3005210579",
          "3005700659",
          "3003335547",
          "3010086866",
          "3009380063",
          "3010972758",
          "3003477135",
          "3000209794",
          "3004369318",
          "3010531069",
          "2182207",
          "3015200795",
          "3006705815",
          "2183744",
          "2649622",
          "3010052483",
          "3019807891",
          "2648729",
          "3013023969",
          "3004593495",
          "1928237",
          "3002618605",
          "3000203466",
          "1627487"
        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}