BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 20562 · Received March 1, 1995

    Report

    Report Number
    20562
    Event Type
    Injury
    Date Received
    March 1, 1995
    Date of Event
    September 2, 1994
    Report Date
    October 12, 1994
    Manufacturer
    TELECTRONICS
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WENT TO MD'S OFFICE FOR PACER CHECK. MD FOUND NO OUTPUT AT ALL BEFORE END OF GENERATOR LIFE. HOSPITALIZED FOR EXPLANT AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS Implant PACEMAKER PULSE GENERATOR DXY TELECTRONICS 8222

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization