BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3941932 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13183
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A URINARY TRACT INFECTION IN (B)(6) 2013 THAT TRIGGERED THE SPASTICITY, BUT IT WAS MANAGED AND UNDER CONTROL BY INCREASING THE PUMP. PER THE CONSUMER, THERE HAD BEEN A TIME WHERE THE PUMP WAS BEING INCREASED AND NOTHING WAS HAPPENING. THEN, THE PUMP WAS INCREASED 20% AT ONCE AND THE PATIENT EXPERIENCED SOME RELIEF. THE PUMP WAS THEN INCREASED ANOTHER 10% IN (B)(6) 2014 AND THE PATIENT¿S RIGIDITY COMPLETELY WENT AWAY. IT WAS NOTED THAT ON (B)(6) 2013 AT A PUMP REFILL, THE DOSE WAS INCREASED 7%; THE PUMP ADMINISTERED LIORESAL INTRATHECAL (500 MCG/ML) AT A DOSE RATE OF 115.99 MCG/DAY. ON (B)(6) 2014, THE LIORESAL INTRATHECAL (500 MCG/ML) DOSE RATE WAS 186.15 MCG/DAY. LATER ON (B)(6) 2014, INFORMATION WAS RECEIVED FROM THE CONSUMER WHO PROVIDED ADDITIONAL INFORMATION REGARDING THE COURSE OF EVENTS (THE YEAR OF OCCURRENCE WAS NOT PROVIDED FOR MANY OF THE DATES). ON (B)(6) 2013, THE DOSE WAS INCREASED 10%, ON (B)(6) [2013] THE DOSE WAS DECREASED 7% BECAUSE IT WAS THOUGHT IT WAS TOO MUCH. THE PATIENT WAS HOSPITALIZED (DATE AND DETAILS WERE NOT PROVIDED). ON (B)(6), THE PUMP BATTERY WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. ON (B)(6), THE DOSE WAS INCREASED 5%, ON (B)(6) THE DOSE WAS INCREASED 2%, ON (B)(6) THE PUMP WAS REFILLED AND INCREASED 7%. ON (B)(6), THE DOSE HAD BEEN DECREASED 5%, IN BETWEEN, THE PATIENT HAD BEEN HOSPITALIZED WITH A URINARY TRACT INFECTION, WAS ADMINISTERED IV ANTIBIOTICS. IT WAS NOTED THAT ONCE THE ANTIBIOTICS KICKED IN, THE PATIENT WAS ¿LOOSY GOOSY.¿ ON (B)(6), THE DOSE WAS INCREASED 8%, ON (B)(6) THE DOSE WAS INCREASED 5%, AND ON (B)(6) THE DOSE WAS INCREASED 10%. MRI¿S WERE PERFORMED WHICH INDICATED THAT THE PATIENT HAD NOT EXPERIENCED ANY MULTIPLE SCLEROSIS FLARES. ON (B)(6), A DYE STUDY WAS CONDUCTED AND PRODUCED NEGATIVE RESULTS. ON (B)(6), THE PATIENT¿S PUMP WAS REFILLED WITH LIORESAL INTRATHECAL AND WAS INCREASED 20%. ON (B)(6), THE DOSE WAS INCREASED 10% AND THE LIORESAL CONCENTRATION WAS 500 MCG/ML, DOSE RATE 186.15 MCG/DAY. IN (B)(6) 2014, THE PATIENT HAD A URINARY TRACT INFECTION WHICH HAD BOTHERED THE PATIENT¿S MULTIPLE SCLEROSIS AND ¿PUT HIM BACK INTO THE RIGIDITY PROBLEMS¿, HIS URINE SMELLED, AND HAD HIGH BLOOD PRESSURE IN THE EVENINGS AROUND 5-6 PM. THE PATIENT HAD A HISTORY OF HYPERTENSION AND WAS PUT ON LASIX. THE PATIENT¿S BLOOD PRESSURE WAS 136/90 AND WAS AS HIGH AS 164/105 WHEN HE WAS ON ANTIBIOTICS. THE PATIENT HAD A STANDING ORDER FOR CEFPODOXIME; THE PATIENT DID A WEEK¿S WORTH AND THEN A WEEK¿S WORTH OF DOXYCYCLINE. ON (B)(6), THE CULTURE CAME BACK WHICH INDICATED E. COLI, ¿OVER ONE HUNDRED THOUSAND¿ AND ¿THIRTY THOUSAND FOR STENOTROPHOMONAS MALTOPHILIA.¿ THE PATIENT WAS PUT ON LEVOQUIN FOR 7 DAYS, BUT THE PATIENT¿S URINE DID NOT SMELL THE WAY IT HAS SMELLED IN MAY. THE PATIENT WAS PUT ON THREE TYPES OF ANTIBIOTICS AND WAS IMPROVING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE PATIENT SUFFERS FROM CHRONIC UTI¿S. PER THE HCP WHEN THE PATIENT HAS A UTI THEIR SPASTICITY INCREASES AND THE HCP HAS TO INCREASE THE DOSE. ONCE THE PATIENT FINISHES THE ANTIBIOTICS, THE PATIENT BECOMES TOO LOOSE AND THEY HAVE TO LOWER THE PATIENT AGAIN. PER THE HCP THE PATIENT HAS NEVER BEEN OVERDOSED AND THAT THE UTI¿S ARE NOT BELIEVED TO BE RELATED TO THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418239 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other