BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELECTRONICS

    MDR report key: 309009 · Received December 14, 2000

    Report

    Report Number
    MW1020607
    Event Type
    Malfunction
    Date Received
    December 14, 2000
    Date of Event
    December 12, 2000
    Report Date
    December 14, 2000
    Manufacturer
    TELECTRONICS
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATRIAL LEAD FAILURE. GENERATOR AND LEAD REMOVED IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS PACEMAKER ATRIAL LEAD DTB TELECTRONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR