BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFIX

    MDR report key: 146347 · Received January 26, 1998

    Report

    Report Number
    1723248-1998-00024
    Event Type
    Malfunction
    Date Received
    January 26, 1998
    Date of Event
    March 13, 1998
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS PARTIALLY EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. A PORTION OF THE LEAD BODY AND J WIRE REMAIN. EXPLANT METHOD: INTRAVASCULAR SUPERIOR TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET NO COMPLICATIONS.

    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 NA Other| R