{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "108418",
      "product_res_number": "Z-0894-2013",
      "event_date_initiated": "2012-03-28",
      "event_date_posted": "2013-02-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-08-15",
      "res_event_number": "61554",
      "product_code": "MHY",
      "product_description": "Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG,  Model 6788 Implantable Pulse Generator.",
      "code_info": "Model number 6788.  All lots manufactured prior to 03/16/2012 are being recalled.",
      "firm_fei_number": "1627487",
      "recalling_firm": "Advanced Neuromodulation Systems Inc.",
      "address_1": "6901 Preston Rd",
      "city": "Plano",
      "state": "TX",
      "postal_code": "75024-2508",
      "additional_info_contact": "Local SJM Representative\n972-309-2154",
      "reason_for_recall": "Unintended Fluid ingress into the device header has been shown.",
      "root_cause_description": "Device Design",
      "action": "St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.   Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical.  Their local representatiave would collect the unused inventory.  Any unused product would be replaced with product once inventory becomes available.  For patients with implanted product and no degradation of therapy, it is recommended dthat the devices not be unnecesssarily explanted.  For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter.  Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action.  Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication.\r\nFor questions regarding this recall call 972-309-2154.",
      "product_quantity": "388 units",
      "distribution_pattern": "Worldwide Distribution - 53 consignees out of the US.",
      "openfda": {
        "pma_number": [
          "P140009",
          "P960009"
        ],
        "registration_number": [
          "3018094310",
          "3013023969",
          "3019807891",
          "2649622",
          "3038429246",
          "3006630150",
          "3005210579",
          "2024311",
          "1928237",
          "2133772",
          "1627487",
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          "3010972758",
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          "2133641",
          "3009380063",
          "3010086866",
          "2182207",
          "3003335547",
          "3005160949",
          "9616693",
          "3010052483",
          "3006705815",
          "3015924373",
          "2135338",
          "2648729",
          "2124215",
          "3004209178"
        ],
        "fei_number": [
          "3018094310",
          "3013023969",
          "3019807891",
          "3000203466",
          "2649622",
          "3038429246",
          "3006630150",
          "3005210579",
          "2024311",
          "1928237",
          "1627487",
          "3010531069",
          "3004593495",
          "3003120897",
          "3010972758",
          "3002618605",
          "2183744",
          "3004369318",
          "3003477135",
          "3005700659",
          "3009380063",
          "3010086866",
          "2182207",
          "3000209794",
          "3003335547",
          "3005160949",
          "3010052483",
          "3006705815",
          "3015924373",
          "2648729",
          "2124215"
        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}