BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFIX

    MDR report key: 96184 · Received May 30, 1997

    Report

    Report Number
    1723248-1997-00418
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    October 1, 1996
    Report Date
    May 29, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z2095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PREVIOUSLY RPT'D AS NO REASON FOR REMOVAL. THE LEAD WAS EXPLANTED DUE TO A RPT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR. TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET, INTRAVASCULAR COUNTER TRACTION, SHEATH(S). 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 71 YR Other