BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3981745 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13986
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# VA0HHDH, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ON PROGRAM 3 AT 1.7VOLTS WITH LIGHTNING BOLT. THE PATIENT DOESN¿T FEEL THE STIMULATION. THE PATIENT ADJUSTED UP TO 1.9 VOLTS AND STATES THE STIMULATION WAS COMFORTABLE. THE CALLER REPORTS THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT SPOKE WITH HER HCP(HEALTHCARE PROVIDER) AND IT WAS REVIEWED THEY FELT THE PATIENT HAD A FLU BUG AND WHAT CAUSED A CHANGE IN PATIENTS SYMPTOM CHANGES. THE CALLER STATES THIS WAS THE FIRST TIME IT¿S NOT WORKED IN THE SHORT TIME THAT THE PATIENT HAS HAD THIS. THE CALLER WAS ON THE PHONE TO ASSIST THE PATIENT WITH USING THE PATIENT PROGRAMMER AND READY TO TRY AND SEE IF IT CAN FIX THE PROBLEM. THE CALLER STATES IT STARTED ABOUT A WEEK AGO BUT PATIENT FELT LAST NIGHT IT WASN¿T WORKING. THE CALLER STATES THAT STIMULATOR DEVICE SYSTEM WAS WORKING FINE SINCE PATIENT GOT IT. THE CALLER STATES ON (B)(6) 2014 THE PATIENT FELT A BLAST OF DIARRHEA COME ON AND LASTED 24-36 HOURS THROUGH THE WEEKEND. THE CALLER STATES THAT FOLLOWING MONDAY ON (B)(6) 2014, THEY CALLED THE NURSE AND THEY FELT BAD. THE CALLER STATES ALL THE WEEK LONG PATIENT HASN¿T BEEN FEELING TO WELL. IT WAS NOTED ALL WEEK LONG THE PATIENT HAS FELT NO ENERGY AND WAS TOLD IT MIGHT BE A FLU BUG. THE CALLER STATES WHEN SHE HAD THE SESSION THE BOWEL WAS JUST POURING OUT OF HER. THE PATIENT STATES ALL WEEK LONG SHE DIDN¿T HAVE ANY ISSUES UNTIL LAST NIGHT AND WAS TAKING A SHOWER LAST NIGHT AND STARTED UP IN THE SHOWER OF FECAL ACCIDENT AND THEN THE PATIENT STATES SHE HAD LIGHT FECAL SESSIONS (ACCIDENTS) WHEN SHE GOT UP. THE PATIENT STATES SHE HASN¿T UPDATED THE HCP REGARDING THE NEWEST FECAL ACCIDENTS BUT DID UPDATE THEM LAST MONDAY. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTED THE THERAPY HELPED WITH URINARY INCONTINENCE UNTIL THIS WEEK. THIS WEEK PATIENT¿S SYMPTOMS RETURNED. LAST NIGHT THE PATIENT HAD LEAKAGE EVERY HALF AN HOUR. THE PATIENT USED TO FEEL STIMULATION AND STOPPED FEELING STIMULATION THE NIGHT BEFORE REPORTED EVENT DATE OR SO. ON THE CALL PATIENT WAS NOT ABLE TO CONNECT TO INS (STIMULATOR). THE PATIENT NEVER USED PATIENT PROGRAMMER BEFORE. SHE TRIED REPOSITIONING THE ANTENNA BUT STILL WAS NOT ABLE TO CONNECT. THE PATIENT SAID SHE WOULD WAIT UNTIL HER DAUGHTER GETS HOME TO HELP HER. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IMPLANTED FOR A COMBINATION OF BOTH BLADDER AND BOWEL INCONTINENCE. SOMETIMES WHEN THE PATIENT HAD LEAKAGE THEY TURNED THE STIMULATION UP. THE PATIENT HAD HAD LEAKAGE ON AND OFF SINCE BEING IMPLANTED IN MAY. THE PATIENT WAS WONDERING IF IT WAS OK TO CHANGE THE SETTINGS WHEN THEY HAD LEAKAGE. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT LATELY SHE HAD TO INCREASE STIMULATION MORE OFTEN. SHE NOTICED HER BOWEL SYMPTOMS RETURNED A MONTH OR SO AGO. SHE INCREASED STIMULATION DURING THAT TIME AND IT DID GOOD FOR A SHORT TIME, BUT THEN SHE HAD A PROBLEM AGAIN. HER SETTINGS WERE ABOUT 3.4 VOLTS; IT DID GOOD FOR A COUPLE OF MONTHS, BUT THEN IT GOT GRADUALLY WORSE. THE PATIENT HAD ANOTHER RETURN IN SYMPTOMS WITHOUT REPORTING ANY NEW INTERVENTION OR OUTCOME, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458036 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR