BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 5720368 · Received June 13, 2016

    Report

    Report Number
    3007566237-2016-02253
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    March 23, 2009
    Report Date
    June 13, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS FOR EZW.

    Description of Event or Problem · 1

    A PATIENT INDICATED FOR URINARY DYSFUNCTION REPORTED THEY HAD NOT GOTTEN THERAPY BENEFIT SINCE IMPLANT. THE PATIENT HAD THEIR DEVICE REPROGRAMMED ON THE DAY OF THE CALL AND THEY WERE FEELING STIMULATION, BUT COULD NOT DETERMINE IF THEY WERE GETTING THERAPY BENEFIT YET. WHEN THE PATIENT URINATED, IT WAS LESS THAN THE AMOUNT THAT HE WAS TYPICALLY ABLE TO URINATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375537 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other