BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 296755 · Received September 12, 2000

    Report

    Report Number
    296755
    Event Type
    Injury
    Date Received
    September 12, 2000
    Date of Event
    September 10, 2000
    Report Date
    September 12, 2000
    Manufacturer
    ACCUFIX RESEARCH INSTITUTE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RETENTION WIRE PROTRUDED FROM TELECTRONICS 330-801 ATRIAL LEAD INTO THE AORTA CAUSING CARDIAC TAMPONADE EMERGENCY OPEN HEART SURGERY & REPAIR OF AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS PACEMAKER LEAD DTB ACCUFIX RESEARCH INSTITUTE 330-801 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| O