BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIZM 2 DR

    MDR report key: 624779 · Received May 18, 2005

    Report

    Report Number
    MW1035522
    Event Type
    Death
    Date Received
    May 18, 2005
    Date of Event
    March 15, 2005
    Report Date
    May 18, 2005
    Manufacturer
    GUIDANT, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DIED SUDDENLY - WITNESSED. PT HAD PRIZM 2 MODEL 1861 MFG BY GUIDANT. IT WAS REMOVED AND FOUND TO BE NON-FUNCTIONAL DUE TO A MFG DEFECT THAT IS PRESENT IN ALL MODELS MFG PRIOR TO 4/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT, INC. 1861 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death