BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 294708 · Received September 7, 2000

    Report

    Report Number
    MW1019854
    Event Type
    Injury
    Date Received
    September 7, 2000
    Date of Event
    August 23, 2000
    Report Date
    August 23, 2000
    Manufacturer
    PACESETTER ASSOCIATES, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS PACEMAKER DXY PACESETTER ASSOCIATES, INC. 1256 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention