BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX II DEC

    MDR report key: 109270 · Received July 24, 1997

    Report

    Report Number
    1723248-1997-00575
    Event Type
    Injury
    Date Received
    July 24, 1997
    Date of Event
    July 9, 1997
    Report Date
    July 22, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z2095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX 8MM PROXIMAL OF THE WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX 80MM AND HAS MIGRATED DOWN LEAD BODY APPROX 23MM PROXIMAL OF WELD SITE.

    Description of Event or Problem · 1

    DEVICE ANALYSIS IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX II DEC Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 033-812 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other