{
  "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": "205296",
      "product_res_number": "Z-0780-2024",
      "event_date_initiated": "2023-12-19",
      "event_date_posted": "2024-01-22",
      "recall_status": "Open, Classified",
      "res_event_number": "93714",
      "product_code": "LGW",
      "pma_numbers": [
        "P840001"
      ],
      "product_description": "Model A710 Intellis Clinician Programmer Application, version 2.0.97",
      "code_info": "UDI/DI 00763000520076, S/N: NPL1000519",
      "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": "Jeffrey Trauring\n763-514-2000",
      "reason_for_recall": "Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.",
      "root_cause_description": "Under Investigation by firm",
      "action": "OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.",
      "product_quantity": "1 tablet",
      "distribution_pattern": "Germany",
      "openfda": {
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        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}