BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2844593 · Received November 26, 2012

    Report

    Report Number
    3007566237-2012-02827
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    October 28, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BEEN "COMPLAINING ON AND OFF" FOR A MONTH PRIOR TO THE REPORT THAT HER VAGINA HURT IN CERTAIN POSITIONS. IT WAS NOTED THAT THE PATIENT HAD URINARY TRACT INFECTIONS "ALL THE TIME" AND WAS TAKING MEDICATION FOR ONE AT THE TIME OF THE REPORT. IT WAS FURTHER REPORTED THAT THE PAIN IS "KIND OF CLOSER TO THE PATIENT'S RECTUM." IT WAS ALSO NOTED THAT THE PATIENT IS WEARING A DIAPER SO THEY CANNOT TELL IF SHE IS HAVING ACCIDENTS. THE PATIENT REPORTEDLY HAD HER SETTINGS CHANGED IN (B)(6) 2012 AND WAS ADJUSTED DOWN TO 4 VOLTS AND THEN BACK UP TO 5 VOLTS BECAUSE THE PATIENT WAS HAVING THE SAME ISSUE WITH "HURTING IN CERTAIN POSITIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention