BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DR HE

    MDR report key: 1253911 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40799
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DR HE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention THE DEVICE 0180/101699 WAS IMPLANTED 04-APR-2006| THE DEVICE E110/002053 WAS IMPLANTED 18-SEP-2008