BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR 033757

    MDR report key: 62099 · Received January 6, 1997

    Report

    Report Number
    1723248-1997-00023
    Event Type
    Malfunction
    Date Received
    January 6, 1997
    Date of Event
    October 30, 1996
    Report Date
    January 3, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF INTER ELECTRODE REGION KINKED WITH WIRE FRACTURE NOT SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCOR 033757 Implant CARDIOVASCULAR PERMANENT PACING ELECTRODE DTB TELECTRONICS PACING SYSTEMS 033-757 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other