BEUDAMED
    FDA Adverse Event Summary report: N

    MAXIMO II

    MDR report key: 2193355 · Received July 7, 2011

    Report

    Report Number
    2193355
    Date Received
    July 7, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    NIK
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR MALFUNCTION SECONDARY TO RAPID BATTERY DEPLETION. CARDIOVERTER-DEFIBRILLATOR DEVICE HAS AN EXPECTED 4 - 5 YEAR BATTERY LIFE. RAPID BATTERY DEPLETION MAY BE RELATED TO CHRONIC HIGH LEFT VENTRICULAR OUTPUT AS WELL AS RECURRENT TACHYARRHYTHMIA. DEVICE HAS BEEN REQUESTED BY MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DEFIBRILLATOR, CRT NIK MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MANAGEMENT D284TRK *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR