BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3799978 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08717
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 16, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT STIMULATION HELPED FOR A WHILE BUT "NOW IT'S KINDA GOING BACK TO THE WAY IT WAS BEFORE." THE PATIENT STATED, THE CHANGE HAS BEEN GRADUAL BUT IT'S BEEN "ABOUT 2-3 MONTHS NOW" THAT IT HASN'T WORKED AS WELL. THE PATIENT STATED THAT "NOW I CAN'T MAKE IT TO THE BATHROOM AT ALL BEFORE I'M WET." THE PATIENT STATED, SHE HAS DEVICE SET ON PROGRAM 2 AT 2.1 AND THAT SHE HAS INCREASED AND DECREASED AND IT DOESN'T SEEM TO HELP. CALLER STATED SHE HAS TRIED STIMULATION ON ALL 4 PROGRAMS. THE PATIENT STATED THAT SHE RECEIVED NO DIRECTION FROM HER DOCTOR ON WHEN IT WAS APPROPRIATE TO CHANGE PROGRAMS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE STIMULATION WAS TURNED ON, THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE EVENT OR SYMPTOMS STARTED ABOUT ONE WEEK OR SO AGO. THE PATIENT REPORTS SHE DID FALL A COUPLE OF TIMES AND WAS NOT SURE WHETHER THIS WAS TIED TO IT NOT WORKING. THE PATIENT FELL ABOUT 2-3 WEEKS AGO FIRST AND AGAIN LAST WEEK. IT WAS NOTED NOT WORKING ON THE PROGRAM IT¿S ON. THE PROBLEM STARTED ABOUT ONE WEEK OR SO GO. THE PATIENT WAS FEELING THE STIMULATION BUT NOT WORKING. THE PROBLEM WAS OCCURRING BEFORE IT WAS PLACED. THE PATIENT WAS GOING THRU A BUNCH OF CLOTHES. THE PATIENT HAD FALLEN A COUPLE OF TIMES AND WONDER IF SHE DID SOMETHING. THE PATIENT FALL WAS LAST WEEK AND ANOTHER FALL WAY BACK WHEN THE PATIENT STATES ABOUT TWO OR THREE WEEKS. IT WAS NOTED THAT THE PATIENT FELL ON BOTTOM. IT WAS REPORTED THE ONLY FALL CLOSE TO IMPLANT WAS LAST WEEK. THE PATIENT FELL BACK AGAINST THE WALL AND HIT THE WALL WITH BACK. (B)(6) 2012 WAS NOTED. THE PATIENT¿S LEFT ARM HAS BEEN BOTHERING TOO MUCH AND HASN¿T BEEN ABLE TO USE IT. IT WAS NOTED GOING ON 3-4 MONTHS BUT HEALTHCARE PROVIDERS WERE WORKING ON IT. IT WAS NOTED THAT THE PATIENT IN PROGRAM 3 AT 4.1 VOLTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279340 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR