{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "186320",
      "product_res_number": "Z-1368-2021",
      "event_date_initiated": "2021-03-09",
      "event_date_created": "2021-04-07",
      "recall_status": "Open, Classified",
      "res_event_number": "87569",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009"
      ],
      "product_description": "A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and\n3.0.1057*\n* Version 3.0.1057 is approved for distribution in Europe only.",
      "code_info": "version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.",
      "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": "Lindsey Dickinson\n763-514-2000",
      "reason_for_recall": "There are two issues within this correction action:\n1. Cycling Issue:\nWhen copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the \"replacement\" function of the A610 clinician programmer application, the cycling feature is not copied properly.\n2. Log Fill Issue:\nWhen the Percept PC INS System Event log is full, the\nclinician programmer A610 Software application version\n2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Beginning 9-Mar-2021, Medtronic representatives began verbally notifications in order to inform impacted physicians of the issues and provide the mitigations outlined in the letters.  Beginning 16-Mar-2021, Medtronic notified its consignees via mail, email, fax, and/or personal visit by Medtronic personnel.  The notice described the problems and provided a workaround to use until a software update is available.",
      "product_quantity": "5332 downloads",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom.",
      "openfda": {
        "pma_number": [
          "P960009",
          "P140009"
        ],
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        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}