{
  "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": "122514",
      "product_res_number": "Z-0279-2014",
      "event_date_initiated": "2013-09-30",
      "event_date_posted": "2013-11-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-11-20",
      "res_event_number": "66506",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009"
      ],
      "product_description": "Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603.  Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.",
      "code_info": "all serial numbers",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave NE",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-3568",
      "additional_info_contact": "Technical Services\n800-707-0933",
      "reason_for_recall": "Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions:  Switching between groups with Multiple programs or creating program groups.  Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).",
      "root_cause_description": "Software design",
      "action": "In September 2013 Medtronic issued a medical device correction letter titled \"Loss of Stimulation and Over Stimulation\" to customers associated with the affected Medtronic neurostimulators. This letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues.  Medtronic field representatives will be updating the model 8870 software application card to version AAR/01, which is contained in the physician programmer.  A Physician Reply Form was asked to be signed and returned by fax or mail for acknowledging the receipt of the Urgent Medical Device Correction letter.  When the Medtronic field rep updates the software application card of the physicains' programmer, they will complete a Rep Reply For:  8870 Card Update to AAR/01.",
      "product_quantity": "62,634",
      "distribution_pattern": "Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.",
      "openfda": {
        "pma_number": [
          "P960009",
          "P140009"
        ],
        "registration_number": [
          "3003120897",
          "3015924373",
          "3006630150",
          "9616693",
          "3038429246",
          "3018094310",
          "2024311",
          "3005160949",
          "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"
      }
    }
  ]
}