BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 41933 · Received September 19, 1996

    Report

    Report Number
    41933
    Event Type
    Injury
    Date Received
    September 19, 1996
    Date of Event
    September 3, 1996
    Report Date
    September 13, 1996
    Manufacturer
    TELTRONICS
    Product Code
    DTB
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERFORATION OF ARTERIAL J LEAD DEMONSTRATED BY FLUORO; CT NOTED HEMOPERICARDIUM. J-WIRE (RETENTION WIRE) 3 1/4" IN LENGTH DISLODGED FROM ATRIAL LEAD AND PERFORATED RF FREE WALL. REMOVED WITH GOOSENECK SNARE THROUGH MULLINS TRANSEPTAL SHEATH. NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS Implant J-WIRE DTB TELTRONICS 330-801 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention
    2