{
  "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": "37340",
      "product_res_number": "Z-0604-05",
      "event_date_initiated": "2005-02-09",
      "event_date_posted": "2005-03-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-12-28",
      "res_event_number": "31142",
      "product_code": "NIK",
      "pma_numbers": [
        "P010031S005"
      ],
      "product_description": "Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia.  Therapies are automatically delivered following detection or can be initiated via programming by the physician.  These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.",
      "code_info": "Model 7289 InSync II Marquis (serial numbers listed include all affected devices but may include some unaffected devices.  Patients are recommended to check with their doctor for exact serial numbers affected.)     S-Series:  PRJ600001 - PRJ609639S and PRJ614813 - PRJ614815S",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Managment",
      "address_1": "7000 Central Ave Ne",
      "city": "Fridley",
      "state": "MN",
      "postal_code": "55432",
      "additional_info_contact": "Tim Samsel\n763-514-3149",
      "reason_for_recall": "Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism.  Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.",
      "root_cause_description": "Other",
      "action": "Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information.  The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care.",
      "product_quantity": "7235 ONLY distributed within US",
      "distribution_pattern": "worldwide",
      "openfda": {
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P050023",
          "P910023",
          "P030054",
          "P010031",
          "P060027",
          "P880086",
          "P000009",
          "P030035",
          "P880006",
          "P010012",
          "P970013"
        ],
        "registration_number": [
          "3015453963",
          "3008159616",
          "3018094310",
          "9616693",
          "3013288201",
          "3003120897",
          "2017865",
          "2182208",
          "3013500228",
          "3005334138",
          "3006705815",
          "2124215",
          "3008494315",
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          "3033257494",
          "2032521",
          "3009380063",
          "9610139",
          "3005941719",
          "1000165971"
        ],
        "fei_number": [
          "3015453963",
          "3003574398",
          "3002618605",
          "3008159616",
          "3018094310",
          "3013288201",
          "3003120897",
          "2017865",
          "2182208",
          "3013500228",
          "3005334138",
          "3006705815",
          "2124215",
          "3002807576",
          "3000203466",
          "2648729",
          "1028232",
          "3013596024",
          "3012552532",
          "3002806500",
          "3002806603",
          "3033257494",
          "3009380063",
          "3008377825",
          "3002807111",
          "1000165971"
        ]
      }
    }
  ]
}