BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3800126 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08723
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 15, 2014
    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
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CHANGE IN THERAPY EFFECT. THE PATIENT HAD NOT GOTTEN AS GOOD OF BENEFIT AS EXPECTED FROM THE PUMP. THIS HAD BEEN GOING ON FOR ABOUT THE PAST YEAR. THE HEALTH CARE PROVIDER (HCP) WOULD PROGRAM A DOSE INCREASE WHICH WOULD WORK FOR A COUPLE OF DAYS AND THEN THE PATIENT WOULD HAVE A RETURN OF SPASTICITY. A DYE STUDY WAS DONE LAST WEEK AND EVERYTHING CHECKED OUT OKAY. THE DYE DISPERSED IN THE INTRATHECAL SPACE AS EXPECTED. A ROLLER STUDY WAS PERFORMED AND NO PROBLEM WAS FOUND. IT WAS THOUGHT THE ROTOR MOVED AT LEAST 60 DEGREES, BUT ANOTHER HCP INDICATED THAT IT ONLY MOVED 43 DEGREES. IT WAS NOTED THE BOLUS WAS MISTAKENLY PROGRAMMED FOR 8 MINUTES INSTEAD OF 1 MINUTE. THE PUMP HAD BEEN REPROGRAMMED TO DELIVER 1278 MICROGRAMS PER DAY ON A FLEX PATTERN WITH A BASAL RATE OF 25 MICROGRAMS PER HOUR AND 115 MICROGRAM BOLUSES DELIVERED OVER 5 MINUTES EVERY 4 HOURS AND THAT ¿DIDN¿T HELP¿ THE PATIENT. THE PUMP WAS REPROGRAMMED TO SIMPLE CONTINUOUS MODE ON APRIL 7 DELIVERING 1405 MICROGRAMS PER DAY. THE PUMP WAS BEING USED TO DELIVER BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EXACT SYMPTOMS THE PATIENT HAS HAVING INCLUDED LACK OF BENEFIT TO LEGS AND CONTINUED SPASTICITY DESPITE INCREASING DOSE. IT WAS CONFIRMED THE DYE STUDY AND ROLLER STUDY DONE ON (B)(6) 2014 REVEALED NORMAL RESULTS. THE PATIENT WAS DOING NO BETTER; THE HEALTH CARE PROVIDER (HCP) INCREASED HER PUMP TEN PERCENT AFTER THE STUDY AND ANOTHER FIFTEEN PERCENT WITH A REFILL. NO DEVICES WOULD BE RETURNED. IT WAS LASTLY NOTED THE PATIENT HAD RETURNED TO ANOTHER HCP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279549 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR