BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3971857 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13797
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE THAT THE PATIENT STATES THE STIMULATOR DEVICE THERAPY WAS NOT WORKING. THE PATIENT WAS ALSO INQUIRING ABOUT PATIENT PROGRAMMER USE SPECIFICALLY THE BLUE BUTTONS ON THE SIDE OF THE PATIENT PROGRAMMER THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTS THIS ISSUE BEGAN WEDNESDAY OR THURSDAY AFTER IMPLANT (MONDAY). THE PATIENT STATES SHE WAS GETTING RELIEF FOR THE FIRST FEW DAYS AND THEN IT STOPPED WORKING. THE PATIENT STATES HER GRANDDAUGHTER WAS OVER AND TRIED TO HELP HER USE THE CONTROLLER, BUT IT'S STOPPED WORKING AGAIN. THE PATIENT STATES SHE WAS TIRED OF WETTING HERSELF. THE PATIENT REPORTS THEY WERE ON PROGRAM 1 AT 2.1 VOLTS. THE PATIENT TURNED STIMULATION UP. THE PATIENT STATES SHE WAS NOW AT PROGRAM 1 AT 2.3 VOLTS AND SHE FEELS IT. THE PATIENT WANTED TO TRY A DIFFERENT PROGRAM. THE PATIENT WAS WALKED THROUGH CHANGING TO PROGRAM 2 AT 2.3 VOLTS. THE PATIENT MENTIONS SHE HAS HAND TREMORS AND HAS HAD THEM FOR YEARS. THE PATIENT STATES SHE HAS A HARD TIME WRITING THINGS DOWN AND USING THE PATIENT PROGRAMMER DUE TO THESE TREMORS. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT LEFT VOICEMAIL THAT SHE WAS HAVING A PROBLEM WITH URINATION, CAN¿T FEEL THE STIMULATION AND HAVING ISSUE TRYING TO GET IT TO WORK AND NEEDS SOMEONE TO CALL HER BACK TO ASSIST. THE PATIENT STATES SHE WAS ON PROGRAM 1 AT 2.3 VOLTS WITH LIGHTNING BOLT. THE PATIENT STATES SHE WAS FEELING IT AT 2.5 VOLTS. THE PATIENT DECIDED TO ADJUST UP TO 2.6 VOLTS. THE PATIENT STATES SHE REALIZED THIS MORNING SHE WASN¿T HOLDING HER URINE. THE PATIENT STATES SHE HAS GOTTEN THIS TO WORK FOR HER BEFORE AND WITH HER ESSENTIAL TREMORS IN HER HANDS IT WAS HARD TO HOLD THE ANTENNA IN PLACE. THE PATIENT STATES SHE GOT A COUPLE OF TIMES THROUGH THE NIGHT AND MADE IT TO THE BATHROOM. THE PATIENT STATES WHEN SHE GOT UP THIS MORNING SHE NOTICED SHE WASN¿T HOLDING THE URINE AS WELL. THE PATIENT STATES SHE HAS ESSENTIAL TREMORS AND STATES IT MAKES IT DIFFICULT FOR HER TO HOLD THINGS. THE PATIENT STATES SHE WAS FINE NOW AND ISSUE WAS A RESOLVED OF NEEDING TO USE HER PATIENT PROGRAMMER AND ADJUSTING HER SETTINGS. PATIENT LACKED BASIC UNDERSTANDING OF PATIENT PROGRAMMER USE. THE PATIENT STATES SHE SEES HEALTHCARE PROVIDER ON 07/17/2014 FROM FOLLOW-UP FROM THE SURGERY. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS NOT FEELING STIMULATION AND WAS URINATING. THE PATIENT LEFT A VOICEMAIL THAT STATES SHE WAS NOT FEELING PULSING FROM HER STIMULATOR AND SHE WAS URINATING. THE PATIENT SAID THE STIMULATOR WORKED FOR A WHILE AFTER AN ADJUSTMENT YESTERDAY AND THEN LATE LAST NIGHT THE STIMULATION STOPPED WORKING. THE PATIENT USED THE PROGRAMMER TO CHECK THE DEVICE AND SHE WAS ON, PROGRAM 1 AT 2.6 AMP. THE PATIENT INCREASED THE STIMULATION TO 2.9 AMP AND SHE FELT THE STIMULATION. THE PATIENT WILL TRY THIS SETTING AND FOLLOW UP WITH HER HCP (HEALTHCARE PROVIDER). THE PATIENT INCREASED THE STIMULATION TO 2.9 AMP AND SHE FELT THE STIMULATION. THE PATIENT WILL TRY THIS SETTING AND FOLLOW UP WITH HER HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446518 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR