BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC INSYNC MARQUIS

    MDR report key: 597095 · Received April 18, 2005

    Report

    Report Number
    597095
    Event Type
    Other
    Date Received
    April 18, 2005
    Date of Event
    January 27, 2003
    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. THE PATIENT HAS A HISTORY OF DOCUMENTED RECURRENT VENTRICULAR TACHYCARDIA AND IT HAS BEEN DECIDED THAT THE BEST APPROACH TO MANAGING THE SITUATION WOULD BE TO REPLACE THE PATIENT'S ICD PER THE MEDICAL DOCTORS HISTORY AND PHYSICAL.

    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 63 YR