BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6105993 · Received November 16, 2016

    Report

    Report Number
    3004209178-2016-24133
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    April 26, 2016
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE IS APPROXIMATE YEAR VALID. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER IMPLANTED FOR URINARY DYSFUNCTION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION AND A GRADUAL RETURN OF SYMPTOMS. AN X-RAY WAS TAKEN OVER A MONTH AGO AND THE PATIENT NOTICED A CHANGE IN SYMPTOMS ABOUT 1-2 DAYS AFTER. THE PATIENT REPORTEDLY WAS WORKING MORE PHYSICALLY DUE TO THEIR NEW JOB AND INCREASED THEIR WATER INTAKE BY 2 GLASSES. STIMULATION FOUND TO BE OFF THE NIGHT PRIOR TO THE REPORT SO THE PATIENT TURNED IT ON AND INCREASED SETTINGS, BUT THEN DECREASED BECAUSE IT WAS TOO STRONG. HOWEVER, STIMULATION WAS NOT FELT 2 HOURS LATER. REPROGRAMMING WAS REVIEWED AND IT WAS RECOMMENDED THAT THE PATIENT TRACK CHANGES AND RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757958 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR