BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3173791 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10497
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V358329, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PROBLEM WITH THE PATIENT PROGRAMMER. THE BASIC FUNCTIONALITY WAS REVIEWED WITH THE PATIENT. THE PATIENT WAS CURRENTLY ON PROGRAM 1 AT 0.0 V, BUT WAS UNABLE TO CHANGE TO A DIFFERENT PROGRAM. IT WAS NOTED THAT THE PATIENT DID NOT GET A NEW PATIENT PROGRAMMER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S PHYSICIAN WAS TRYING TO CHANGE PROGRAMS, BUT WAS UNABLE TO CHANGE PROGRAMS. THE PHYSICIAN WAS ABLE TO SYNC, TURN STIMULATION ON/OFF, TOGGLE THROUGH ICONS, BUT COULD NOT GET THE BOTTOM ROW TO VIEW OTHER PROGRAMS. IT WAS REVIEWED THAT THE PHYSICIAN WOULD NEED TO USE THE CLINICIAN PROGRAMMER TO ADD THE DESIRED PROGRAMS, AS EITHER THEY DID NOT EXIST OR HAD NOT BEEN SET UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT (B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED WHEN INITIAL PROGRAMMING WAS DONE AT THE TIME OF IMPLANT ONLY ¿PROGRAM 1¿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¿MINOR INCONVENIENCE¿ FOR THE PATIENT AND HER PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS NOT COMING ON. THEN THE PATIENT WAS ABLE TO GET THE PROGRAMMER TO WORK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD A FOLLOW-UP VISIT ON (B)(6) 2014. THE PATIENT WAS DOING WELL WITH THE DEVICE, WAS VERY PLEASED, AND JUST TOOK SOLIFENACIN SUCCINATE IF GOING OUT. THE BUTTOCKS INCISION WAS GREAT AND THE BATTERY WAS NOT FELT BY THE PATIENT. SOME PALPATION WAS ABLE ON THE ELECTRODE CONNECTOR, BUT IT WAS NOT UNCOMFORTABLE FOR THE PATIENT. THE PATIENT HAD IMPROVED BLADDER QUIETING WITH THE REPROGRAMMING OF THE DEVICE. THE PATIENT WOULD RETURN TO THE HCP'S OFFICE IN 6 MONTHS. THE INDICATION FOR USE FOR THIS PATIENT WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274113 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR