BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5770100 · Received July 5, 2016

    Report

    Report Number
    3004209178-2016-13517
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    June 10, 2016
    Report Date
    August 31, 2016
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT REPORTED SOMETHING MOVED LATE THE THURSDAY NIGHT PRIOR TO THE REPORT AND THEY WOKE UP LEAKING. STIMULATION WAS PRESENT AND THEY WERE ON PROGRAM 1 AT 2.1V. THE PATIENT SAID THEY ADJUSTED IT SEVERAL TIMES AND PARTLY FEEL STIMULATION. IT FELT LIKE SOMETHING MOVED SLIGHTLY AND ONLY FEEL PART OF IT "ZING" OR BUZZ, "IT IS NOT BUZZING WHERE IT WAS". ON THE FRIDAY PRIOR TO THE REPORT, THEY INCREASED TO 2.3 VOLTS AND IT WAS UNCOMFORTABLE SO THEY LOWERED TO 2.2 AND WAS STILL UNCOMFORTABLE SO THEY LOWERED TO 2.1 AND STAYED THERE. DURING THE REPORT THE PATIENT NOTED IT WAS NOT THE WAY IT WAS AFTER SURGERY. ON ONE SIDE THEY CAN FEEL IT. THE PATIENT THEN SWITCHED TO PROGRAM 2 AT 2.2 VOLTS. THE SYMPTOMS REPORTED INCLUDE GOING EVERY 30-45 MINUTES. IT'S NOT A STEADY STREAM AND THEY FEEL URGENCY. THEY HAVE MAJOR LEAKAGE IF THEY WAIT MORE THAN AN HOUR. SINCE THE FRIDAY PRIOR TO THE REPORT, IT'S NOT A TINY DRIBBLE, MORE LIKE A RIVER AND IF IT HAS BEEN AN HOUR AND A HALF THEY FEEL DISCOMFORT AND REALLY NEED TO GO. THE IMPLANTABLE NEUROSTIMULATOR (INS) IS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION/GASTROINTESTINAL/PELVICFLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT MET WITH THEIR HEALTHCARE PROVIDER (HCP) ON (B)(6) 2016, AND BEGAN MEDICATION ON (B)(6) 2016. AN X-RAY WAS PERFORMED ON (B)(6) 2016 AND A BLADDER SCAN OCCURRED ON (B)(6) 2016. THE TRIAL WORKED PERFECTLY AND THE INS WORKED PERFECTLY, TOO, FOR 15 DAYS AFTER IMPLANT. THERE WERE NO CHANGES IN ACTIVITY LEVEL AND NOTHING TO EXPLAIN WHY THE INS ¿ABRUPTLY STOPPED WORKING.¿ THE PATIENT INDICATED THEY WENT TO THE GROCERY STORE THE DAY BEFORE AND WOKE UP THE MORNING TO ¿GREAT URGENCY¿ AND INCONTINENCE BEFORE THEY COULD MAKE IT TO THE BATHROOM. IT WAS NOTED THAT IT ¿SEEMED AS THOUGH SOME CONNECTION CAME LOOSE¿ AND IT WAS ¿VERY DEPRESSING.¿ THE HCP PUT THE PATIENT ON TOLTERODINE TARTRATE, BUT THE LOSS OF URINE WAS GREATER SINCE IT WAS ADMINISTERED. EVERY TIME THE PATIENT STOOD UP, IT WAS ¿LIKE SOMEONE PULLED A PLUG AND URINE GUSHED¿ EVEN IF THE PATIENT URINATED 20 MINUTES BEFORE. THINGS WERE MUCH WORSE THAN BEFORE THE INS. SYMPTOMS HAD NOT RESOLVED AND THE PATIENT FELT ¿THINGS NEEDED TO BE REDONE.¿ THE PATIENT WANTED TO DO SOME WATER AEROBICS AND SWIMMING BUT COULD NOT IN GOOD CONSCIENCE DUE TO THE LEAKY BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423278 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR