BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCUFIX 23~

    MDR report key: 30635 · Received January 12, 1996

    Report

    Report Number
    30635
    Event Type
    Other
    Date Received
    January 12, 1996
    Date of Event
    June 29, 1995
    Report Date
    July 25, 1995
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAD INITIALLY REPORTED AS FRACTURED WHEN VIEWED FLUOROSCOPICALLY. WAS CONFIRMED AS FRACTURED ON EXPLANT TODAY. A SINGLE FRACTURE IS LOCATED NEAR THE LEAD TIP, BUT NOT AT THE WELDED JUNCTION OF "J-WIRE" AND ANODE. EASY EXPLANT AND PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX 23~ Implant ATRIAL J-WIRE PACEMAKER LEAD DTB TELECTRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other