BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 95377 · Received May 30, 1997

    Report

    Report Number
    1723248-1997-00419
    Event Type
    Injury
    Date Received
    May 30, 1997
    Date of Event
    March 9, 1995
    Report Date
    May 30, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z2095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED SEGMENT OF THE J WIRE HAS MIGRATED IN THE AREA OF LEFT PULMONARY ARTERY. ON 3/9/95, THE MIGRATING SEGMENT OF J WIRE WAS REMOVED. THE LEAD BODY AND A PORTION OF THE J RETENTION WIRE REMAIN IN SITU. EXPLANT METHOD: THORACOTOMY 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 58 YR Required Intervention