{
  "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": "84736",
      "product_res_number": "Z-0170-2010",
      "event_date_initiated": "2006-12-22",
      "event_date_posted": "2009-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-07-23",
      "res_event_number": "53128",
      "product_code": "LGW",
      "pma_numbers": [
        "P010032/S14/"
      ],
      "product_description": "Eon Rechargeable Implantable Pulse Generator (IPG) System",
      "code_info": "Model number 3701 charging system is an accessory to the 3716 IPG; antennas are not serialized.",
      "firm_fei_number": "1627487",
      "recalling_firm": "Advanced Neuromodulation Systems, Inc",
      "address_1": "6901 Preston Rd",
      "city": "Plano",
      "state": "TX",
      "postal_code": "75024-2508",
      "reason_for_recall": "Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.",
      "root_cause_description": "Device Design",
      "action": "12/22/2006, Marketing Update 5015 was issued to field sales representatives providing information on improving communication between the Internal Pulse Generator and its charger.  May 15, 2007, Marketing Update 5022 was issued to field sales representatives to reiterate avoiding contact between the charger antenna and conductive materials and place the preferred side of the charging antenna face-down over the implant.  Troubleshooting Guide was created in January 2008 for field sales representatives and technical services departments regarding isolation of the communication issue to the external devices instead of the implanted component.  March 25, 2008, the Clinician's Manual was updated adding a recommendation for a minimum depth of pocket for device implantation.",
      "product_quantity": "24,750 units total",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "pma_number": [
          "P840001",
          "P130022",
          "P130028",
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        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}