BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY

    MDR report key: 6172529 · Received December 13, 2016

    Report

    Report Number
    3007566237-2016-04379
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    TRIAL PATIENT CALLED STATING THAT THE RIGHT LEAD HAS PULLED OUT OF HER BODY AND WAS STILL CONNECTED TO THE ENS. THE PATIENT NOTICED IT WHEN SHE GOT UP OFF THE COMMODE THIS MORNING AND FELT IT DANGLING. THERE WAS NO SYMPTOM REPORTED RELATED TO LEAD COMING OUT. SUPPORT LINK WAS ABLE TO HELP HER SWITCH TO THE LEFT LEAD AND RESUME THERAPY. THE PATIENT WAS TO FOLLOW UP WITH HCP REGARDING LEAD THAT CAME OUT OF THE PATIENT BODY. PATIENT HAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2016, BUT WILL CALL HCP BEFORE THEN. PATIENT ALSO REPORTED THAT SHE FELT BURNING PAIN IN THE VAGINAL AREA WHEN SHE VOIDS. PATIENT CONFIRMED THAT THIS WAS A PREEXISTING CONDITION THAT SHE'S HAD FOR OVER THREE YEARS. THE PAIN WAS ABOUT THE SAME AS BASELINE AND NO WORSE SINCE THE START OF THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823343 VERIFY STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3531

    Patients

    Seq Age Sex Outcome Treatment
    1