BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 706694 · Received April 28, 2006

    Report

    Report Number
    2124215-2006-99411
    Event Type
    Death
    Date Received
    April 28, 2006
    Date of Event
    April 3, 2006
    Report Date
    April 28, 2006
    Manufacturer
    *
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPIRED FIVE DAYS POST IMPLANT. THERE WAS AN ALLEGATION BY A FAMILY MEMBER, THAT THE DEVICE FAILED TO DELIVE RTHERAPY DURING CARDIAC ARREST. IT WAS REPORTD PATIENT WAS STILL UNDER HOSPITAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS * T165 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death