BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC INSYNC MARQUIS

    MDR report key: 590482 · Received April 8, 2005

    Report

    Report Number
    590482
    Event Type
    Other
    Date Received
    April 8, 2005
    Date of Event
    December 1, 2003
    Report Date
    April 8, 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 HISTORY OF CARDIOMYOPATHY WITH LEFT VENTRICULAR EJECTION FRACTION, HTN, PVD, PREVIOUS ICD IMPLANT 9/2003. UPGRADE TO BIVENTRICULAR ICD IN 12/2003, FOLLOWED IN OFFICE. ICD RECENTLY CHECKED IN OFFICE AND NOTED THAT DEVICE THAT THE PATIENT HAS IS A MEDTRONIC INSYNC MARQUIS DEVICE HAS HAD A RECALL. IT WAS DECIDED THAT THE PATIENT'S DEVICE 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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR