BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3853365 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10245
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA0FS1U, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. DISPLAY SHOWED "CALL YOUR DOCTOR" ICON WITH A POR (POWER ON RESET) CONDITION. NO STIMULATION SENSATION WAS NOTED. PROGRAMMER SHOWED POR- SHORTLY AFTER THE PATIENT GOT HOME FROM IMPLANT. THERE WAS A RETURN OF SYMPTOMS - ABOUT 2 WEEKS AGO. THE PATIENT NOTED SHE WAS NOT SURE HOW TO USE HER INTERSTIM ICON. WHEN THE PATIENT FIRST GOT THE IMPLANT, SHE DID NOT FEEL ANY STIMULATION BUT SHE WAS NOT HAVING ANY PROBLEMS WITH BOWEL INCONTINENCE. THEN, THE LAST COUPLE WEEKS -BOWEL SYMPTOMS HAD RETURNED. PATIENT SERVICES ASKED THE PATIENT TO TRY THE PROGRAMMER WHILE ON THE PHONE. THE PATIENT WAS SEEING POR AND CALL YOUR DOCTOR ON THE SCREEN AND THE WARNING SYMBOL. IT WAS NOTED THAT EVERY TIME SHE TURNS THE PROGRAMMER ON, SHE SEES THIS SCREEN. AT FIRST THE PATIENT, NOTED SHE FIRST SAW THIS SCREEN A COUPLE WEEKS AGO AND THEN AT THE END OF THE CONVERSATION THE PATIENT STATED SHE SAW THIS SCREEN RIGHT AFTER SHE CAME HOME FROM THE IMPLANT BUT SHE DIDN'T THINK ANYTHING OF IT BECAUSE SHE WAS NOT HAVING ANY SYMPTOMS. NOW, FOR THE PAST TWO WEEKS HER SYMPTOMS HAD BEEN GUSHY. THE PATIENT STATED SHE HAD BEEN HOME. IT WAS NOTED THAT THE PATIENT COULD GET THE POR SCREEN TO GO AWAY IF SHE PRESSED THE INS ON BUTTON. WHEN THE PATIENT GETS THE SYNCH SCREEN WITH A TRIANGLE, AND THEN WHEN SHE PRESSES THE SYNCH BUTTON SHE GETS THE POR SCREEN. PATIENT SERVICES ASKED THE PATIENT TO TRY TO CLEAR WITH THE NAVIGATOR BUTTON, BUT WAS UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332002 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR