BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 99918 · Received June 23, 1997

    Report

    Report Number
    99918
    Event Type
    Injury
    Date Received
    June 23, 1997
    Date of Event
    June 11, 1997
    Report Date
    June 17, 1997
    Manufacturer
    ATROTECHOY
    Product Code
    GZE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ATROSTIM JUKKA, AN FDA PROVISIONAL DEVICE FOR DIAPHRAGMATIC PACING, WAS INSERTED INTO THIS 5 YEAR OLD CHILD ON 11/13/96. ON 6/9/97, THE CHILD WAS BROUGHT TO MEDICAL CENTER WITH SIGNS OF LEFT SIDED PACER FAILURE. ON 6/11/97 THE CHILD WAS TAKEN TO THE OR AND IT WAS NOTED THAT THE CONNECTING WIRE HAD SOME "SKIP LESIONS" AND DISINTEGRATION OF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant * GZE ATROTECHOY FE4BR 0496

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| O