BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3974050 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13863
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    February 28, 2011
    Report Date
    July 10, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP WAS IMPLANTED IN 2011 AND WENT INTO A NURSING HOME AND THE PUMP HAD NOT BEEN FILLED SINCE THEN. IT WAS UNKNOWN WHAT DRUG THE PUMP WAS BEING USED TO DELIVER. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS NOW BEING SEEN BY A NEW NEUROLOGIST WHO WAS NOT A BIG SUPPORTER OF INTRATHECAL BACLOFEN THERAPY SO HE WANTED TO PUT THE PATIENT ON ORAL BACLOFEN FIRST. IT WAS NOTED IF THAT DID NOT WORK HE PLANNED TO DO A NEW TRIAL AND WOULD EXPLANT THE OLD SYSTEM AND IMPLANT A NEW ONE RATHER THAN TRYING TO SEE IF THE CURRENT SYSTEM WAS STILL FUNCTIONAL. IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER (HCP) DID NOT PLAN TO PUT SALINE IN THE PUMP OR DO ANYTHING WITH IT AND THE PUMP HAD NOT BEEN READ. IT WAS UNKNOWN WHAT CONCENTRATION AND DOSE WERE PROGRAMMED AFTER IMPLANT. IT WAS ALSO REPORTED ¿IT DIDN¿T SOUND LIKE THE PATIENT WENT THROUGH WITHDRAWAL OR ANYTHING,¿ BUT SPECIFIC DETAILS WERE NOT PROVIDED. THE PUMP WAS BEING USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S NEW HCP WAS VERY CONSERVATIVE AND WANTED TO START THE PATIENT ON ORAL BACLOFEN FOR A WHILE FIRST. IT WAS NOTED HE WANTED TO DO AN INTRATHECAL BACLOFEN (ITB) TRIAL ALL OVER AGAIN IF NEEDED AND THEN HAVE THE ENTIRE SYSTEM REPLACED IF NEEDED. THE PATIENT WAS NEVER REFILLED IN THE NURSING FACILITY AND SHE ¿FELL THROUGH THE CRACKS.¿ IT WAS UNKNOWN IF THE PATIENT EXPERIENCED ¿WITHDRAWS OR ANYTHING ELSE.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451140 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR