{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "43204",
      "product_res_number": "Z-0370-06",
      "event_date_initiated": "2005-11-30",
      "event_date_posted": "2006-01-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-12-28",
      "res_event_number": "34156",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009"
      ],
      "product_description": "Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components:  Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions.  Medtronic, Inc. 710 Medtronic  Parkway, Minneapolis, MN  55432-5604, USA.  The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain.  The Neurostimulator generates electrical signals that are transmitted to the brain.  These signals are delivered from the neurostimulator to the brain via Extension and Lead.  These components comprise the implantable portion of the Activa System.",
      "code_info": "All serial numbers and Lot codes are affected.",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Inc, Neurological & Spinal Division",
      "address_1": "800 53rd Ave Ne",
      "city": "Columbia Heights",
      "state": "MN",
      "postal_code": "55421-1241",
      "reason_for_recall": "A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging).  Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg.  The recommended  maximum displayed head SAR is now 0.1 W/kg.",
      "root_cause_description": "Other",
      "action": "The firm''s recall consists of providing revised instructions for the Activa DBS. The revision modifies the recommended SAR to use during MRI of patients who have an Activa DBS. Use of the Activa DBS is otherwise unaffected by this recall.  A Dear Healthcare Provider letter and MRI Radiologist letter were sent on 11/30/05 and 12/05/05 to provide this information.",
      "distribution_pattern": "Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America",
      "openfda": {
        "pma_number": [
          "P960009",
          "P140009"
        ],
        "registration_number": [
          "2024311",
          "3005210579",
          "3019807891",
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          "3006630150",
          "3010972758",
          "2133641",
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          "3004593495",
          "3005160949",
          "3009380063",
          "3010052483",
          "2135338",
          "3038429246"
        ],
        "fei_number": [
          "3005700659",
          "3002618605",
          "2024311",
          "3005210579",
          "3019807891",
          "3010531069",
          "1627487",
          "3018094310",
          "3003120897",
          "2182207",
          "3010086866",
          "3006705815",
          "2124215",
          "3013023969",
          "2649622",
          "3000203466",
          "2648729",
          "3003335547",
          "3003477135",
          "1928237",
          "3006630150",
          "3000209794",
          "2183744",
          "3004369318",
          "3010972758",
          "3015924373",
          "3004593495",
          "3005160949",
          "3009380063",
          "3010052483",
          "3038429246"
        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}