BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 212418 · Received February 17, 1999

    Report

    Report Number
    1723248-1999-00083
    Event Type
    Injury
    Date Received
    February 17, 1999
    Date of Event
    April 11, 1995
    Report Date
    February 16, 1999
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT DESCRIBED IS A TRANSLATION OF THE FRENCH PHYSICIANS LETTER. AN X-RAY PERFORMED APPROX FEB 01, 1995 REVEALED THE J SHAPE RETENTION WIRE WAS FRACTURED AND HAD MIGRATED INTO THE RIGHT PULMONARY. THE PATIENT PRESENTED AT THE SAME MOMENT WITH PENETRATION SYNDROME DUE TO THE MIGRATED WIRE. AT THE SCANNER, A PORTION OF THE J WIRE COULD BE SEEN IN THE RIGHT LOBE BRONCHIAL TUBE. AT THE FIBROSCOPY, THEY SAW A PROTRUSION INSIDE THE LUMEN OF THE BRONCHIAL TUBE OF APPROX 8MM. THE MIGRATED SEGMENT IS ABOUT 4/5 CM AND OVERLAPS THE RIGHT PULMONARY ARTERY AND THE ADJACENT BRONCHIAL TUBE. THE PORTION OF THE J WIRE WAS EXTRACTED VIA BRONCHOSCOPE ON APPROX APRIL 4, 1995.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention