BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4122033 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17805
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 4, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V120757, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DO NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS THINKING THE BATTERY IN HER HIP IS DEAD AND WOULD LIKE TO KNOW HOW TO FIND OUT. SHE CAN'T CONTROL HER URINE, IF SHE GETS UP SHE WAS GOING. THE PATIENT SYMPTOMS STARTED ACTUALLY THE DAY BEFORE REPORTED EVENT DATE. A FEW DAYS AGO IT WAS NOT SO BAD BUT NOW THEY WERE OUT OF CONTROL. THE CALLER REPORTS A LOSS OF THERAPEUTIC EFFECT. STIMULATION WAS TURNED ON AND ON PROGRAM 2 AT 4.0 VOLTS. SHE HAS HAD NO FALLS OR TRAUMAS. WANTED TO CHANGE PROGRAMS AND INCREASE STIMULATION TO SEE IF THAT WOULD HELP WITH SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600674 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR