{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "32530",
      "product_res_number": "Z-0812-04",
      "event_date_initiated": "2004-04-02",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-11-29",
      "res_event_number": "28798",
      "product_code": "LWS",
      "pma_numbers": [
        "P980016"
      ],
      "product_description": "Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271",
      "code_info": "Manufacturing Dates from May 1997 to August 1998;  and  Use Before Dates from November 1998 to February 2000.",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Managment",
      "address_1": "7000 Central Ave N.E.",
      "city": "Fridley",
      "state": "MN",
      "postal_code": "55432",
      "additional_info_contact": "Tim Samsel\n763-514-3149",
      "reason_for_recall": "Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.",
      "root_cause_description": "Other",
      "action": "A letter, dated April 2004, was sent on April 5, 2004 to  physicians following patients who had the defibrillators implanted.  The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem.   Physicians are being visited by sales representatives to verify notification.",
      "product_quantity": "250 units (34 units in the United States)",
      "distribution_pattern": "Nationwide in the United States and worldwide.",
      "openfda": {
        "pma_number": [
          "P010031",
          "P900061",
          "P980016",
          "P880086",
          "P940008",
          "P030035",
          "P970024",
          "P980050",
          "P010012",
          "P830060",
          "P970013",
          "P110042",
          "P030054",
          "P930035",
          "P910023",
          "P910073",
          "P890061",
          "P910077",
          "P880006",
          "P980049",
          "P050023",
          "P950022",
          "P960040",
          "P920015",
          "P980023",
          "P940024",
          "P220012"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3015453963",
          "2011171",
          "3008159616",
          "1000121056",
          "1225687",
          "3008988055",
          "3010288227",
          "3018094310",
          "9616693",
          "3013288201",
          "3003932293",
          "3003120897",
          "2017865",
          "2182208",
          "3013500228",
          "3005334138",
          "3006705815",
          "3004105270",
          "2124215",
          "3008494315",
          "1423662",
          "9614453",
          "2135338",
          "2649622",
          "2183787",
          "2648729",
          "3003276151",
          "3014461810",
          "3015544746",
          "3004209178",
          "3008973940",
          "2183744",
          "1028232",
          "3013596024",
          "3012552532",
          "1828132",
          "3004961578",
          "2133641",
          "3010273872",
          "3002806603",
          "2030624",
          "2022502",
          "3002807314",
          "3002807561",
          "3004593495",
          "3033257494",
          "2032521",
          "3009380063",
          "3013674629",
          "3011120183",
          "9610139",
          "1000165971"
        ],
        "fei_number": [
          "3005700659",
          "3015453963",
          "3003574398",
          "3002618605",
          "2011171",
          "3008159616",
          "1000121056",
          "3008988055",
          "3010288227",
          "3018094310",
          "3013288201",
          "3001451463",
          "3003932293",
          "3003120897",
          "2017865",
          "2182208",
          "3013500228",
          "3005334138",
          "3006705815",
          "3004105270",
          "2124215",
          "3002807576",
          "2649622",
          "2183787",
          "2648729",
          "3000203466",
          "3003276151",
          "3014461810",
          "3015544746",
          "3008973940",
          "2183744",
          "3004369318",
          "1028232",
          "3013596024",
          "3012552532",
          "1828132",
          "3002806500",
          "3004961578",
          "3010273872",
          "3000215273",
          "3000206435",
          "3002806603",
          "2022502",
          "3002807561",
          "3002807314",
          "3004593495",
          "3033257494",
          "3009380063",
          "3013674629",
          "3008377825",
          "3011120183",
          "1000165971"
        ]
      }
    }
  ]
}