BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2961836 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02647
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V667542, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS SHOCKING HER AND 'HURTING HER LEGS.' IT WAS ALSO STATED THAT THE DEVICE WAS ON "TOO HIGH" AND IT WAS SET AT 8 VOLTS. IT WAS NOTED THAT THE PATIENT'S PROGRAMMER STOPPED WORKING DUE TO USING RECHARGEABLE BATTERIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)() 2013 NOTED THAT THE PATIENT WAS GOING TO THE BATHROOM ABOUT 4 TIMES A NIGHT AND DAY WITH A LOSS OF THERAPEUTIC EFFECT. SYMPTOMS CHANGED ABOUT 2 WEEKS AGO. THERE WAS NO FALL OR TRAUMA. THE PATIENT TURNED STIM UP ABOUT A MONTH AGO AND IT SHOCKED HER. THE PATIENT WANTED TO TRY DIFFERENT SETTING TO SEE IT WILL HELP HER SYMPTOMS. THE PATIENT WAS ON P1 @ 2.7V. THE PROGRAM WAS CHANGED TO P2 @ 0.3V. PROGRAM 2 WAS TOO HIGH AND WAS SHOCKING HER. THE INS WAS TURNED OFF AND STIM TURNED DOWN TO 0. THE PATIENT THEN SLOWLY INCREASED STIM TO A COMFORTABLE LEVEL. THE PATIENT WAS CONSTIPATED. THE PATIENT PLANNED TO SEE THEIR HEALTHCARE PROVIDER IN FOLLOW UP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65733 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1