{
  "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": "2026-09-05",
    "results": {
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  "results": [
    {
      "cfres_id": "186742",
      "product_res_number": "Z-1535-2021",
      "event_date_initiated": "2021-03-25",
      "event_date_created": "2021-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "87674",
      "product_code": "LGW",
      "product_description": "Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator  Intellis Model 97716 Implanted Neurostimulator.",
      "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": "Jeff Trauring\n763-514-2000",
      "reason_for_recall": "There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Beginning 25-Mar-2021, Medtronic began notifying physicians in the US and consignees OUS via mail, email, fax, and/or personal visit by Medtronic personnel.  In the US, each implanting physician was sent the medical device correction letter, the patient quick guide, and the customer confirmation form.  Outside the US, the medical device correction letter, the patient quick guide, and the customer confirmation form were sent to the healthcare facilities.  Additionally, on an ongoing basis, the patient quick guide will be provided with each replacement recharger.",
      "product_quantity": "79,616 units",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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