BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC INSYNC MARQUIS

    MDR report key: 595312 · Received April 18, 2005

    Report

    Report Number
    595312
    Event Type
    Other
    Date Received
    April 18, 2005
    Date of Event
    January 26, 2004
    Report Date
    April 18, 2005
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NIK
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC RECALL OF ICD GENERATOR DEVICE SECONDARY TO POSSIBLE BATTERY MALFUNCTION. PATIENT WITH A HISTORY OF MASSIVE ANTERIOR WALL MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE, CORONARY ARTERY BYPASS GRAFT X2, CONGESTIVE HEART FAILURE, ISCHEMIC CARDIOMYOPATHY, VENTRICULAR TACHYCARDIA STATUS POST ICD. PATIENT NOTIFIED BY THE PHYSICIAN OF THE MEDTRONIC ICD RECALL. GIVEN THE PATIENT'S INDIVIDUAL SITUATION WITH A HISTORY OF RECEIVING THERAPY FROM ICD IN THE PAST, IT HAS BEEN DECIDED THAT THE GENERATOR SHOULD BE REPLACED. (PER MD H&P)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INSYNC MARQUIS ICD NIK MEDTRONIC INC. 7289 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR