{
  "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,
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  },
  "results": [
    {
      "cfres_id": "184732",
      "product_res_number": "Z-0860-2021",
      "event_date_initiated": "2020-11-12",
      "event_date_created": "2021-01-14",
      "recall_status": "Open, Classified",
      "res_event_number": "86872",
      "product_code": "LGW",
      "product_description": "Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.",
      "code_info": "Software version 1.3.80",
      "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": "Medtronic Neuromodulation Technical Services*\n800-707-0933",
      "reason_for_recall": "A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.",
      "root_cause_description": "Software design (manufacturing process)",
      "action": "Medtronic notified the first consignee by letter on 11/12/2020 with a confirmation of their complaint and request to perform a correction to the device which put the device in a factory-reset state and restore functionality to allow programming and continued therapy. \n\nOn 17 Dec 2020, Medtronic will begin issuing an Urgent Medical Device Correction notification to physicians regarding this validation error and providing instructions on the impact and appropriate mitigating actions if this issue presents.",
      "product_quantity": "7960 downloads",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.",
      "openfda": {
        "pma_number": [
          "P840001",
          "P130022",
          "P130028",
          "P800040",
          "P030017",
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        ],
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}