BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3749056 · Received April 14, 2014

    Report

    Report Number
    3004209178-2014-07191
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 24, 2014
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V800436, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE PATIENT REPORTS DISPLAY SHOWING "CALL YOUR DOCTOR" ICON. THE PATIENT REPORTS A POR (POWER ON RESET) CONDITION. THE PATIENT WENT TO CHANGE THE SETTINGS LAST NIGHT WHEN THEY NOTICED THIS ON THEIR PROGRAMMER. THE PATIENT LEFT A MESSAGE WITH THEIR HEALTHCARE PROVIDER BUT HASN'T HEARD BACK YET FROM THEM. THE PATIENT HAD AN X- RAY LAST WEEK. THE PATIENT LATER CLARIFIED THAT SHE HAD A HEAD CT SCAN AND NOT AN X- RAY LAST WEEK OR THE WEEK BEFORE. THE PATIENT HAD A FALL ABOUT 5 WEEKS AGO WHICH WAS WHY THEY WANTED TO DO THE HEAD CT SCAN. THE PATIENT STATES THEY ALSO DID AN ECHOCARDIOGRAM. THE PATIENT STATES 3 OF THEIR LEADS ARE UP TO 8.5 VOLTS AND 1 OF THE LEADS WAS BEING USED AT 8.0 VOLTS. THE PATIENT WAS HAVING LEAKING, THEY WAS TRYING TO INCREASE THIS AS WELL WHEN THEY NOTICED THE POR (POWER ON RESET) ON THEIR PROGRAMMER. THE PATIENT HAS HAD THE STIMULATOR FOR 3 YEARS AND THINKS THEIR BATTERY WAS ALMOST DOWN. THE PATIENT HAS PUT NEW BATTERIES IN THEIR PROGRAMMER BUT THE OTHER BATTERY WAS SHOWING DOWN TO ABOUT 1/8TH. THE PATIENT WAS UNABLE TO CONFIRM IF THEY WERE SEEING THE STIMULATOR BATTERY PICTURE DUE TO THE POR (POWER ON RESET) MESSAGE ON THE PROGRAMMER. THE PATIENTS¿ HEALTHCARE PROVIDER TOLD THEM LAST YEAR THAT THEY WILL PROBABLY HAVE TO HAVE STIMULATOR CHANGED SOMETIME THIS YEAR. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CALLER WAS TRYING TO CONTACT A MANUFACTURER REPRESENTATIVE FOR A POR (POWER ON RESET). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A POR (POWER ON RESET) CONDITION. THIS WAS REPORTED THE DAY BEFORE THIS REPORTED EVENT DATE WHEN THE PATIENT CALLED THE MANUFACTURER. THE PATIENT REPORTS THAT THEY DID CALL THEIR HEALTHCARE PROVIDER BUT THEY TOLD THE PATIENT TO CALL THEIR MANUFACTURER REPRESENTATIVE, WHO WAS NOT ANSWERING THEIR PHONE TODAY OR YESTERDAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014. IT WAS ALSO NOTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226725 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR