BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFIX

    MDR report key: 85941 · Received April 17, 1997

    Report

    Report Number
    1723248-1997-00281
    Event Type
    Malfunction
    Date Received
    April 17, 1997
    Date of Event
    September 10, 1996
    Report Date
    April 15, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z209/211-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED AS SUSPECTED J RETENTION WIRE FRACTURE WITHOUT PROTRUSION. THE CORRECT EVENT DESCRIPTION IS AS FOLLOWS: THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION WITH MIGRATION AWAY FROM THE LEAD BODY.

    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