{
  "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": "112696",
      "product_res_number": "Z-0025-2013",
      "event_date_initiated": "2012-09-04",
      "event_date_posted": "2012-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-05-12",
      "res_event_number": "63154",
      "product_code": "LGW",
      "pma_numbers": [
        "P010032"
      ],
      "product_description": "The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need.\n\n\n\nProduct Usage:\nEon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.",
      "code_info": "Eon Mini - 3788 (IPG), Multiple Serial Numbers",
      "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": "Technical Services Department \n800-727-7846",
      "reason_for_recall": "Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful.  SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "ST. Jude Medical sent  an important Medical Device Advisory letter dated September 4, 2012 to all affected customers.  The letter identified the affected product, problem and recommended actions to be taken.  For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.",
      "product_quantity": "56 units",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "pma_number": [
          "P840001",
          "P130022",
          "P130028",
          "P800040",
          "P030017",
          "P210037",
          "P010032",
          "P190002"
        ],
        "registration_number": [
          "3012693387",
          "2182291",
          "2024311",
          "3005210579",
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          "2183744",
          "3010966701",
          "2133810",
          "9681477",
          "3006630150",
          "3010972758",
          "2133641",
          "3007616088",
          "3015924373",
          "1035166",
          "3021836309",
          "3004593495",
          "2030624",
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          "3013368220",
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          "3008514029",
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          "3009380063",
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        ],
        "fei_number": [
          "3005700659",
          "3003574398",
          "3012693387",
          "3002618605",
          "2182291",
          "3000203066",
          "2024311",
          "3005210579",
          "3014507028",
          "3010531069",
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          "3008988055",
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          "3015200795",
          "2182207",
          "3010086866",
          "3006705815",
          "2124215",
          "3007882731",
          "3013973539",
          "3013023969",
          "3002807439",
          "3027063190",
          "2649622",
          "3000203466",
          "2648729",
          "3003335547",
          "3003477135",
          "1928237",
          "3006630150",
          "3000209794",
          "3010966701",
          "2183744",
          "3004369318",
          "3010972758",
          "3002806500",
          "3007616088",
          "3015924373",
          "1035166",
          "3021836309",
          "3000206435",
          "3005846326",
          "3004593495",
          "3002623849",
          "3005160949",
          "3013368220",
          "3008514029",
          "3015173212",
          "3009380063",
          "3010326622",
          "3010052483",
          "3038429246"
        ],
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}