BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD ENGUARD BIF PF DFT

    MDR report key: 82587 · Received April 8, 1997

    Report

    Report Number
    1316542-1997-00721
    Event Type
    Injury
    Date Received
    April 8, 1997
    Date of Event
    August 12, 1996
    Report Date
    March 28, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAD EXPLANTED DUE TO NOISE OR OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD ENGUARD BIF PF DFT Implant CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 040-068-65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention