BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 203565 · Received December 21, 1998

    Report

    Report Number
    1723248-1998-00749
    Event Type
    Injury
    Date Received
    December 21, 1998
    Date of Event
    October 13, 1998
    Report Date
    December 18, 1998
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR, FEMORAL. TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET, DOTTER BASKET/SNARE, SHEATH(S), LASER. NO COMPLICATIONS. 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 65 YR Required Intervention