BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4192666 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20161
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-33, LOT # VA0KF1R, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 4 WEEKS AGO THE PATIENT WAS CARRYING SOME THINGS FOR A FRIEND AND THEN TRIPPED OVER A DOG AND FELL FORWARD. THE PATIENT HAD A CHANGE IN THEIR BOWELS A COUPLE OF WEEKS AGO AND THEY WERE NOT GOOD WITH REMEMBERING DATES. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND NOTICED 4 TO 5 DAYS AGO THAT THE THERAPY AND DEVICE STOPPED WORKING. THE PATIENT HAD STIMULATION IN THE WRONG LOCATION AND WAS FEELING A DISCOMFORT SENSATION WITH STIMULATION IN THEIR LOWER LEFT BUTTOCKS AREA. THE PATIENT¿S SPOUSE CHANGED THE PROGRAM AND SET IT TOO HIGH INITIALLY AND THEY FELT PAIN IN THEIR LOWER LEFT BUTTOCKS. THE PATIENT TURNED STIMULATION DOWN BUT STILL FELT DISCOMFORT IN THE LOWER LEFT BUTTOCKS. THE PATIENT WAS WALKED THROUGH CHANGING PROGRAMS AND TURNED STIMULATION OFF AND CHANGED TO PROGRAM 4 AND THEY WERE NOT FEELING THE DISCOMFORT IN THE LOWER LEFT BUTTOCK AREA. THE PATIENT FELT STIMULATION IN THE LOWER LEFT BUTTOCK AGAIN ON PROGRAM 4 AT 2.70V AND CHANGED TO PROGRAM 1 AT 2.90V AND FELT STIMULATION IN THE LOWER LEFT BUTTOCK AGAIN AND CHANGED TO PROGRAM 2. THEY FELT STIMULATION IN THE SAME AREA IN THEIR LOWER LEFT BUTTOCKS FOR ALL OF THEIR PROGRAMS 1 THROUGH 4. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671065 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1