BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 141285 · Received December 31, 1997

    Report

    Report Number
    1723248-1997-00930
    Event Type
    Injury
    Date Received
    December 31, 1997
    Date of Event
    July 10, 1997
    Report Date
    December 30, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z2095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE HAS FRACTURED APPROX. 12MM PROXIMAL OF THE WELS SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROX. 76MM AND HAS MIGRATED DOWN LEAD BODY APPROX. 13MM 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 Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention