BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 41136 · Received September 24, 1996

    Report

    Report Number
    41136
    Event Type
    Injury
    Date Received
    September 24, 1996
    Date of Event
    September 18, 1996
    Report Date
    September 23, 1996
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE IS ON ALERT/RECALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R