BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4145756 · Received October 6, 2014

    Report

    Report Number
    3004209178-2014-18379
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V220528, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WHILE STIMULATION WAS TURNED ON LEADING TO INCREASED BASELINE PAIN AND A LOSS OF BLADDER CONTROL. THERE WAS NO KNOWN ACCIDENT. IT HAD BEEN A YEAR AND A HALF SINCE THERAPY HAD WORKED WELL AND SHE HAS HAD MULTIPLE "ACCIDENTS" SINCE THEN. THE PATIENT HAD ONLY ONE PROGRAM. IT WAS REPORTED TWO MONTHS AFTER REPORTED EVENT DATE THAT THE PATIENT VISITED HER PHYSICIAN AND A MANUFACTURER REPRESENTATIVE REGARDING THE EVENT. THE PATIENT WAS NO LONGER HAVING PROBLEMS WITH HER SYSTEM. ADDITIONAL INFORMATION REPORTED THREE MONTHS AFTER PHYSICIAN VISITED, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). SPECIFICALLY, THE PATIENT FELT AN URGENCY LIKE THEY HAD ¿TO GO NOW¿ AND SOMETIMES THEY HAD TO ¿GO AND GO THEN HAS TO GO AGAIN¿. IT WAS NOTED THAT THE THERAPY HELPED FOR A WHILE BUT SINCE 2010 THEY FELT THAT ¿IT STOPPED WORKING¿ AND WAS GETTING WORSE. IT WAS ALSO REPORTED THAT THE PATIENT HAD THE URGENCY ISSUE SINCE 1978 WHEN THEY HAD KIDNEY STONES. THE PATIENT TOOK ORAL MEDICATIONS (RAMOTOL ?) BEFORE THE IMPLANTATION OF THE INS BUT IT DID NOT HELP WITH THEIR URGENCY. THE PATIENT STOPPED TAKING THE MEDICATION WHEN THEY RECEIVED THE INS. THE PATIENT HAD TRIED TO INCREASE THE STIMULATION BUT FELT IT WAS TOO HIGH. IT WAS NOTED LIKE A BOWLING BALL WAS BUSTING THROUGH HER PELVIC FLOOR. THE PATIENT FELT LIKE THEY HAD TO KEEP INCREASING THE STIMULATION TO GET ANY EFFECT FROM THE THERAPY. THE PATIENT WAS UNSURE IF THEY HAD TRIED ANY OTHER PROGRAMS WITH THE DEVICE. THE PATIENT WAS ON PROGRAM 2 AT 5.0 VOLTS AND STIMULATION WAS ON. THE PATIENT WAS ON PROGRAM 3 AT 4 VOLTS SHE COULD NOT FEEL THE STIMULATION. ONE MONTH LATER, FOLLOW UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD AN APPOINTMENT THEY COULD NOT KEEP. THE PATIENT STATED THAT THE DEVICE ¿IS NOT BEHAVING AS IT SHOULD¿ AND HAD GONE AS HIGH AS POSSIBLE WITH NO RELIEF. THE PATIENT NOTED TIRED OF BEING EMBARRASSED WITH IT¿S FAILURE. THE PATIENT DESIRED TO HAVE THE DEVICE REMOVED. ADDITIONAL INFORMATION RECEIVED OVER A YEAR LATER REPORTS THE PATIENT WANTED TO LET US KNOW HER INS (STIMULATOR) HAS BEEN TAKEN OUT. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE REASON SHE HAD THE DEVICE TAKEN OUT WAS FOR THE FIRST THREE YEARS IT WAS GREAT AND THEN IT STOPPED WORKING, IT CEASED TO FUNCTION PROPERLY AND WASN¿T COMPATIBLE WITH MY SITUATION, AND THE INCONTINENCE CAME BACK. IT WAS GREAT FOR THREE YEARS, IT WAS FANTASTIC BUT THEN IT STOPPED GIVING THE PATIENT RELIEF AFTER THREE YEARS. THEY TRIED TO CHANGE THE UNIT AND THE BATTERY AND WOULDN¿T WORK FOR ME ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622826 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention