BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORSAL COLUMN STIMULATOR AND OCTRODE EXTENSION LEAD

    MDR report key: 30584 · Received February 28, 1996

    Report

    Report Number
    MW1008469
    Event Type
    Injury
    Date Received
    February 28, 1996
    Date of Event
    January 18, 1996
    Report Date
    February 21, 1996
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    QUEST MEDICAL, INC. ONE ALLENTOWN PKWY, ALLEN, TX 75002-4211. THIS LETTER IS IN REGARD TO MDR ACCESS NUMBER 1008469, WHICH WAS VOLUNTARILY REPORTED FROM AN ANONYMOUS SOURCE. WE WERE REQUIRED TO EVALUATE THE REPORTED INFO AND DETERMINE WHETHER THE EVENT IS REPORTABLE UNDER THE MDR REQUIREMENTS. AFTER REVIEWING THE MEDWATCH REPORT WE DETERMINED THAT THIS INCIDENT IS NOT REPORTABLE. OUR DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PT GOING INTO RESPIRATORY DEPRESSION FROM MORPHINE. ATTACHED IS A COPY OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORSAL COLUMN STIMULATOR AND OCTRODE EXTENSION LEAD Implant IMPLANTED SPINAL CORD STIMULATOR GZB QUEST MEDICAL, INC. 09P2098, 2098

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R