BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2853237 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10997
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 5, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V168016, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT HAS BEEN HAVING ISSUES STARTING ABOUT A MONTH AGO WHEN SHE HAD TO START USING THE BATHROOM EVERY TWO HOURS. IT WAS REPORTED THAT THE PATIENT HAS HAD TWO FALLS AND TWO STROKES, BUT IT WAS UNKNOWN WHEN THOSE EVENTS TOOK PLACE. THE PATIENT HAD X-RAYS TAKEN "ABOUT A MONTH AGO," AND IT SHOWED "EVERYTHING WAS IN ORDER." THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPROGRAMMED A MONTH AGO, AND IT WAS STATED THAT IT WORKED FOR "ABOUT THREE DAYS AND THEN STOPPED WORKING." IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO SYNC THE INS, WITH OR WITHOUT THE ANTENNA ATTACHED. ONE DAY LATER, IT WAS REPORTED THAT THE PATIENT RECEIVED A REPLACEMENT PROGRAMMER, AND WAS STILL GETTING POOR COMMUNICATION WITH THE ANTENNA ATTACHED. THREE DAYS AFTER THE INITIAL REPORT, IT WAS REPORTED THAT THE PATIENT WAS TRYING TO OPERATE THE ANTENNA AND PROGRAMMER, BUT WAS STILL EXPERIENCING DIFFICULTIES. IT WAS LATER REPORTED THAT THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT WAS USING A NEW PROGRAMMER AND ANTENNA. THE PATIENT CHANGED THE BATTERIES IN THE PROGRAMMER, BUT SHE STILL COULD NOT GET A CONNECTION. IT WAS REPORTED THAT THE PATIENT HAD A FALL ABOUT A MONTH AGO, AND THAT WAS WHEN SHE BEGAN HAVING ISSUES WITH TELEMETRY. IT WAS STATED THAT THE PATIENT HAD X-RAYS "ABOUT TWO WEEKS AGO," AND THE DOCTOR SAID 'EVERYTHING LOOKED GOOD.' IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING A "PINCHING" SENSATION NEAR THE DEVICE SITE WHEN THE PATIENT WAS TRYING TO ACHIEVE TELEMETRY. IT WAS REPORTED THAT THE SENSATION FADED RATHER QUICKLY, BUT HAPPENED TWICE. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER NONE WAS AVAILABLE AT THE TIME OF THIS REPORT. IF MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE WAS A HOME-BOUND AND DID NOT LEAVE THE HOUSE BECAUSE SHE HAD HAD TWO STROKES IN (B)(6) 2012. THE PATIENT WAS USING COMPRESSION DEVICES FOR HER LEGS. THE PATIENT STATED SHE WAS VERY CONFUSED AND SICK OF BEING IN THE HOUSE FROM THE STROKES. IT WAS INDICATED THAT WHEN THE PATIENT WENT TO USE THE PATIENT PROGRAMMER(PP), IT WAS DISCOVERED SHE HAD NOT CHANGED THE AAA BATTERIES FOR A LONG TIME AND IT NEEDED TO BE CHANGED. THE PATIENT CHANGED THE AAA BATTERIES AND THEN WAS ABLE TO POSITION HER ANTENNA OVER HER IMPLANTABLE NUEROSTIMULATOR(INS) AND SYNCH HER PATIENT PROGRAMMER WITH DEVICE. IT SAID PP WAS AT 2.4 V WITH LIGHTING BOLD. PATIENT SERVICES HELPED PATIENT INCREASED AMPLITUDE TO 2.9V. THE PATIENT WAS INSTRUCTED TO HER HEALTH CARE PROVIDER TO DETERMINE WHEN TO CHANGE OR INCREASE PROGRAMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR