BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC, INC

    MDR report key: 101495 · Received June 26, 1997

    Report

    Report Number
    101495
    Event Type
    Malfunction
    Date Received
    June 26, 1997
    Date of Event
    June 10, 1997
    Report Date
    June 10, 1997
    Manufacturer
    MEDTRONICS, INC NEUROLOGICAL DIV
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STIMULATOR LEAD FAILURE RESULTED IN LACK OF RELIEF FROM PAIN IN LOWER BACK AND RESULTED IN NEED FOR ADDITIONAL PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC Implant SPINAL CORD STIMULATOR GZB MEDTRONICS, INC NEUROLOGICAL DIV QUAD PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR