BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY

    MDR report key: 6070350 · Received November 1, 2016

    Report

    Report Number
    3007566237-2016-03849
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT AND IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A JABBING FEELING, RETURN OF SYMPTOMS, AND PROGRAMMER CANNOT FIND THE DEVICE. THE PATIENT REPORTED THAT SHE USED THE PROGRAMMER ON THE NIGHT PRIOR TO THE REPORT TO DECREASE STIMULATION AND WHEN SHE WOKE UP SHE WAS NOT FEELING STIMULATION AT ALL. THE PATIENT WAS STRUGGLING TO CONNECT THE PROGRAMMER TO THE EXTERNAL NEUROSTIMULATOR (ENS); ONCE CONNECTED THE PATIENT REPORTED STIMULATION WAS SET AT 0.0 AND INCREASED IT TO 0.8 AND WAS STILL NOT FEELING STIMULATION. THE PATIENT DID NOT WANT TO INCREASE STIMULATION MORE DURING THE CALL. THE PATIENT REPORTED THAT SHE WAS TO SEE HER PRIMARY HEALTHCARE PROFESSIONAL ON THE MORNING OF THIS REPORT AND WAS GOING TO STOP IN AND SEE THE TRIAL HEALTHCARE PROFESSIONAL AND SEE WHY SHE WAS NOT ABLE TO CONNECT OR FEEL STIMULATION. THE JABBING FEELING WAS NOTED TO BE SUDDEN. THE PATIENT REPORTED SITTING IN A RECLINER AND FELT A JABBING. THE PATIENT REPORTED THE JABBING FEELING WAS REALLY HARD IN THE BACK. THE PATIENT WAS ABLE TO DECREASE STIMULATION AND REPORTED THE JABBING LESSONED THEN WENT AWAY. THE PATIENT ALSO REPORTED A RETURN OF LEAKING. NO OUTCOMES WERE REPORTED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720947 VERIFY STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3531

    Patients

    Seq Age Sex Outcome Treatment
    1