BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3864158 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11314
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    February 18, 2014
    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 3889-28, LOT# V779354, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S MEDICAL HISTORY INCLUDED SPASTIC PARAPARESIS, CERVICAL STENOSIS, CERVICAL MYELOPATHY, NEUROGENIC BLADDER, AND HAD A BLADDER STIMULATOR. IT WAS NOTED THAT THE PATIENT¿S BLADDER STIMULATOR WAS ALSO ACTIVATING MOTOR UNITS IN THE PATIENT¿S LEG AND WAS CAUSING THE PATIENT LEG FATIGUE. IT WAS ALSO REPORTED THAT THE POSITIONING OF THE DEVICE WAS CORRECTED HOWEVER IT WAS UNCLEAR IF THIS WAS REFERRING TO THE PATIENT¿S PUMP OR BLADDER STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 1.5 WEEKS AGO THE PATIENT HAD A DEXASCAN AND WHEN THEY SCANNED THEIR RIGHT SIDE THEIR RIGHT FOOT STARTED TO TWITCH. IT WAS NOTED THAT WAS THE SIDE OF THEIR IMPLANT AND THE PATIENT HAD THEIR IMPLANT ON. WHEN THEY SCANNED THE PATIENT¿S LEFT SIDE THAT DIDN¿T HAPPEN AND THEY HADN¿T NOTICED ANY CHANGES TO STIMULATION AND EVERYTHING WAS FINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED A LETTER AFTER CONTACTING PATIENT SERVICES AND DID NOT KNOW WHICH PROBLEM OR THERAPY THEY WERE INQUIRING ABOUT. THE PATIENT GOT THE DEXASCAN BECAUSE SOMETIMES THEY WERE ON STEROIDS FOR ASTHMA AND THEY WANTED TO CHECK THE PATIENT¿S BONE DENSITY. IT WAS NOTED THAT DURING THE SCAN IT WAS VERY BOTHERSOME AND WAS VERY STRANGE, UNCOMFORTABLE, AND THE PATIENT COULDN¿T HOLD STILL. THE PATIENT DISCUSSED THIS WITH THEIR HEALTH CARE PROVIDER (HCP) BUT NEVER REALLY GOT AN ANSWER AND THE PATIENT ¿GUESSED THAT IT HADN¿T BEEN RESOLVED.¿ IT WAS REPORTED THAT THE PATIENT STILL HAD THAT PROBLEM AND IN THE PAST 3 DAYS THE PATIENT HAD THAT CONTINUAL PROBLEM AND WAS STARTING TO THINK THERE WAS ANOTHER FACTOR COMING INTO PLAY. THE PATIENT WOULD SEE THEIR HCP ON (B)(6) 2014. IT WAS STATED THAT THE PATIENT WOULD THINK THE PROBLEM WAS MORE OR LESS RELATED TO THEIR STIMULATOR AND THEY HAD NOTICED THAT CERTAIN PROGRAMS ON THEIR STIMULATOR HAD CAUSED THE PROBLEM AS WELL SO THEY HAD TO SWITCH PROGRAMS. THE PATIENT WAS PRESENTLY ON PROGRAM 4 AND THE PATIENT HAD BEEN NOTICING THE TWITCHING PROBLEM IN THE LAST 3 DAYS AND HAD ALSO HAD THEIR PERIOD THE LAST 3 DAYS SO THEY WERE WONDERING IF THAT WAS PLAYING A PART. IT WAS REPORTED THAT THE PATIENT HAD NOTICED WHEN IT WAS ¿THAT TIME OF THE MONTH¿ THESE THINGS WERE HAPPENING SO THEY DIDN¿T KNOW IF IT WAS RELATED TO THAT OR JUST BECAUSE OF THE CONDITIONS THEIR BODY HAD SO NOW THAT THEY WERE GETTING OLDER THIS WAS WHAT THEY COULD EXPECT ONCE A MONTH FOR A WEEK. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WOULD BE REPLACED IN 2015 AND THEIR HCP TOLD THEM THAT THIS WAS BASED ON THEIR CURRENT SETTING OF 3.6V SO THEY ESTIMATED THE TIME FOR REPLACEMENT WOULD BE SOMETIME IN 2015. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S HCP HAD CALLED THEM ON (B)(6) 2014 AND TOLD THEM TO TURN THE STIMULATION DOWN. THEY HAD NO FURTHER INFORMATION TO PROVIDE AND DID NOT KNOW IF THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN ON THE SAME PROGRAM AND AMPLITUDE FOR THE PAST YEAR AND THE PATIENT HAD MUSCLE SPASMS AND TOE CURLING IN THE PAST COUPLE OF MONTHS. IN THE PAST MONTH IT HAD BEEN HAPPENING EVERY COUPLE OF DAYS. IT WAS NOTED THAT THE PATIENT WENT IN FOR AN EMG TEST IN LATE (B)(6) 2014 AND THEIR THERAPY WAS ON AND THEY EXPERIENCED INTERFERENCE WITH THE EMG TEST. THE PATIENT COULD NOT RELAX THEIR RIGHT LEG, HAD A MUSCLE SPASM IN THEIR RIGHT LEG, AND THEIR RIGHT TOE WAS CURLING. IT WAS REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) TOLD THEM TO SHUT THERAPY OFF AND THEIR LEG IMMEDIATELY RELAXED. THE PATIENT ALSO HAD AN EMG ON THEIR ARM BUT THERE WAS NO INTERFERENCE WITH THEIR THERAPY. IT WAS NOTED THAT THE PATIENT EXPERIENCE A TOE PULLING SENSATION IN THE RIGHT LEG AND RIGHT TOE QUITE A WHILE AGO AND THEIR HCP REPROGRAMMED THEM AND THE TOE PULLING STOPPED. IT WAS REPORTED THAT THE PATIENT HAD A CT SCAN DONE ON THEIR SINUSES EARLY LAST WEEK AND DURING THE SCAN THE PATIENT'S LEFT LEG STARTED TO HURT AND THEIR ABDOMEN STARTED TO HURT. THE PATIENT DID NOT REPORT THE PAIN TO THEIR HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338432 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention