BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELECTRONICS

    MDR report key: 287416 · Received July 26, 2000

    Report

    Report Number
    MW1019382
    Event Type
    Malfunction
    Date Received
    July 26, 2000
    Date of Event
    July 14, 2000
    Report Date
    July 17, 2000
    Manufacturer
    ST JUDE
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER GENERATOR MALFUNCTION. RETURNED TO MFR VIA REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS PACEMAKER DXY ST JUDE 2182 *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR