BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD ENGUARD BIF PF DFT 100

    MDR report key: 87028 · Received March 15, 1997

    Report

    Report Number
    1316542-1997-00877
    Event Type
    Injury
    Date Received
    March 15, 1997
    Date of Event
    December 27, 1996
    Manufacturer
    TELECTRONICS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNIT WAS EXPLANTED DUE TO A REPORT OF A CONDUCTOR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD ENGUARD BIF PF DFT 100 Implant CARDIOVASCULAR PERMANENT PACEMAKER LEAD DTB TELECTRONICS 040-068 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention