BEUDAMED
    FDA Adverse Event Death Summary report: N

    DASH

    MDR report key: 690136 · Received March 17, 2006

    Report

    Report Number
    2124215-2006-99340
    Event Type
    Death
    Date Received
    March 17, 2006
    Date of Event
    February 1, 2006
    Report Date
    March 7, 2006
    Manufacturer
    ITM
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PT WITH THIS PACEMAKER PASSED AWAY. AN UNK INDIVIDUAL STATED ON HTE PT VERIFICATION FROM THAT THE DEVICE FAILED. THERE WAS NO RECORD OF A CLINICAL OBSERVATION OR COMPLICATION FROM THE PT'S FAMILY, PHYSICIAN OR FIELD REP RIOR TO THIS COMMUNICATION. THE ESTIMATED LONGEVITY FOR THIS DEVICE IS 6.7 YRS AND THE DEVICE WAS IMPLANTED FOR 9 YRS AND 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH IMPLANTABLE PULSE GENERATOR DXY ITM 291-03 *

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death