BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMMIX

    MDR report key: 115132 · Received August 19, 1997

    Report

    Report Number
    2182207-1997-00221
    Event Type
    Other
    Date Received
    August 19, 1997
    Report Date
    February 3, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LHG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    REPORTED AS "PT ALLEGES SAID SPINAL CORD STIMULATION SYSTEM FAILED TO FUNCTION AS INTENDED AND HAD TO BE REMOVED. PT ALLEGES SHE SUSTAINED PERSONAL INJURIES, PAIN AND SUFFERING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMIX Implant IMPLANTABLE STIMULATION LEAD LHG MEDTRONIC, INC. 3982 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other MODEL 7495-10 EXTENSION