BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELECTRONICS

    MDR report key: 41031 · Received September 27, 1996

    Report

    Report Number
    41031
    Event Type
    Death
    Date Received
    September 27, 1996
    Date of Event
    September 16, 1996
    Report Date
    September 18, 1996
    Manufacturer
    TELECTRONICS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT TO CATH LAB FOR REMOVAL OF FRACTURED RETENTION WIRE ATRIAL LEAD OF PACEMAKER. ANOTHER MFR'S LEAD EXTRACTION SOFT TEFLON SHEATH USED INITIALLY - VENTRICULAR WIRE MOVING WITH ATTEMPTS TO EXTRACT. OUTER SHEATH CHANGED TO STIFFER POLY-PROPYLENE SHEATH - COULD NOT NAVIGATE PAST BEND. PT'S BP DROPPED PRECIPITOUSLY (DOWN INTO 50'S). PT CODED AND RUSHED TO OR - SUBCLAVIAN VEIN PUNCTURED - PT UNABLE TO BE RESUSCITATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death