BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS 030-362

    MDR report key: 94776 · Received May 27, 1997

    Report

    Report Number
    1316542-1997-01130
    Event Type
    Injury
    Date Received
    May 27, 1997
    Date of Event
    February 5, 1997
    Report Date
    May 19, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD REPLACED DUE TO A REPORT OF CONDUCTOR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS 030-362 Implant CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 030-362 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention