BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3052866 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06007
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SHAKING ALL OVER, WAS ITCHY EVERYWHERE AND 'ALMOST ALL' OF HER SPASTICITY HAD RETURNED. HER REFILL DATE WAS SCHEDULED FOR 4 DAYS AFTER THE INITIAL REPORT WAS MADE. THE PATIENT WAS NOT SURE IF THE ALARM HAD SOUNDED, SHE THOUGHT SHE HAD HEARD SOMETHING THE PREVIOUS DAY IN THE HOUSE, BUT NOTED THAT WHEN SHE UNPLUGGED HER LAPTOP SHE HADN'T HEARD ANYTHING SINCE. THE PATIENT WAS NOT HAVING ANY OTHER HEALTH PROBLEMS THAT SHE KNEW OF. IT WAS NOTED 'NOTHING'S CHANGED.' THE DEVICE SYSTEM WAS USED TO INFUSE LIORESAL. IT WAS LATER ADDED THAT THE PUMP MALFUNCTIONED. THE PATIENT WAS SCHEDULED ON (B)(6) 2013 FOR REFILL, THE PUMP PRINTOUT SAID REFILL BY (B)(6) 2013. ON (B)(6) 2013 AT 4AM THE PATIENT WOKE UP TO HER LEGS 'TREMORING.' SHE GOT UP AND MOVED AROUND A LITTLE AND THOUGHT SHE MUST HAVE BEEN LAYING THE WRONG WAY BECAUSE IT SEEMED TO HELP SO SHE LAID BACK DOWN. SHE WOKE UP BEFORE 7AM TO SPASMS OF LEGS FROM THE WAIST DOWN AND A 'CONSTANT TREMOR BOTH LEGS.' SHE CALLED THE ON-CALL DOCTOR AND WAS TOLD TO 'TAKE BENADRYL BECAUSE HER PUMP ALARMS DID NOT SOUND.' SHE DID TAKE THE BENADRYL BUT THE PAIN, TINGLING <(>&<)> SPASMS 'JUST GOT WORSE,' SO SHE WENT TO THE LOCAL EMERGENCY ROOM (ER). THE ER DOCTOR GAVE HER 10MG BACLOFEN ORALLY AND TOLD THE PATIENT TO CALL HER BACLOFEN HEALTHCARE PROVIDER (HCP) TO SEE IF THE PATIENT COULD WAIT TILL MONDAY TO SEE THE BACLOFEN HCP OR IF THE PATIENT SHOULD BE TRANSPORTED VIA AMBULANCE AS SOON AS POSSIBLE. THE PATIENT WAS TOLD THAT BECAUSE HER ALARM DIDN'T SOUND SHE SHOULD TAKE THE ORAL BACLOFEN AND WAIT UNTIL MONDAY TO SEE HER BACLOFEN HCP AND WAS SENT HOME FROM THE ER. SATURDAY NIGHT THROUGH EARLY SUNDAY MORNING WERE 'THE WORST' FOR MISERABLE PAIN <(>&<)> SPASTICITY. MONDAY MORNING, THE PATIENT CALLED THE BACLOFEN HCP AT 8AM AND WAS INSTRUCTED TO DRIVE THE 3 HOURS TO THE CLINIC. AT THE CLINIC THE STAFF SAID THAT THE PATIENT WAS SCHEDULED FOR HER REFILL IN THREE DAYS AND THAT THE PUMP 'CAN'T BE OUT.' THE PUMP WAS INTERROGATED; THE EXPECTED RESIDUAL VOLUME WAS 2.6CC. THE HCP DECIDED TO DO THE REFILL AT THAT TIME SO THE PATIENT WOULD NOT HAVE TO MAKE THE LONG TRIP TWICE IN ONE WEEK. IT TOOK HIM 7 STABS IN THE PATIENT'S GUT TO GET THE NEEDLE IN THE PORT,' THE HCP SAID 'IT KEPT GOING SIDEWAYS.' THE ACTUAL RESIDUAL VOLUME WAS 'BARELY 0.3CC.' THE HCP 'STARTED TALKING LIKE HE WASN'T GOING TO REFILL BECAUSE THERE WAS SOMETHING WRONG.' THE PATIENT 'SPOKE UP AND SAID IT IS OBVIOUSLY NOT WORKING BECAUSE IT IS OUT OF MEDICINE, SO WE SHOULD TRY A LITTLE TO SEE IF IT WORKS.' THE HCP 'PUSHED SOME AND WITHIN 1-3 MINUTES SHAKING STOPPED, MOST SPASMS STOPPED AND PAIN WAS BETTER.' THE PATIENT WAS 'JUST REALLY SORE FEELING, LIKE SHE WORKED OUT REALLY HARD.' THE PATIENT 'ASSUMED' IT WAS BECAUSE SHE HAD BEEN 'SO STIFF, TENSE AND SPASTIC FOR 3 DAYS. THE PUMP DOSAGE WAS INCREASED FROM 135 TO 150 (NO UNITS OR RATE WERE REPORTED.) THE PATIENT REPORTED FEELING REALLY SORE AND WEAK, HER LEGS WERE 'SO DARN HEAVY' AND SHE WAS SCARED. AN X-RAY WAS DONE 'TO VERIFY PUMP/TUBING WAS OK,' THE X-RAY 'REVEALED NO ISSUES OF CONCERN.' IT WAS LATER ADDED BY THE BACLOFEN HCP THAT THERE WAS NO INJURY RELATED TO THE EVENT, THE PATIENT MISSED REFILL APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154526 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1