BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3854347 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10285
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 16, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CONFIRMED CATHETER BLOCKAGE. THE HEALTHCARE PROFESSIONAL (HCP) HAD SOME DIFFICULTY ASPIRATING THE CATHETER VIA THE CAP AND THEN A BLACKISH FLUID OF APPROXIMATELY 2CC'S WAS ASPIRATED. THE HCP THEN ASPIRATED ADDITIONAL FLUID FROM THE CAP TO CONFIRM GOOD FLOW. PER HCP DISCRETION, THE CATHETER WAS NOT REVISED NOR THE DAILY DOES DECREASE, BUT THE PATIENT WOULD BE ASSESSED FOR 8 HOURS. THE PUMP CONTAINED CLONIDINE, BUPIVACAINE AND MORPHINE. IT WAS FURTHER REPORTED THE PATIENT HAD NO SYMPTOMS; THE HCP HAD BEEN INCREASING DRUG WITH NOT MUCH PAIN RELIEF. THE CAUSE OF THE CATHETER BLOCKAGE WAS UNDETERMINED, THE ASPIRATED CEREBROSPINAL FLUID (CSF) WAS SENT TO THE LAB FOR MICROSCOPIC STUDY. THE HCP WAS ABLE TO ASPIRATE ADEQUATE CSF FLOW AND CONTINUED THERAPY. THE PATIENT WAS OBSERVED FOR 8 HOURS WITH NO ADVERSE SIDE EFFECTS. THE PATIENT WAS RECEIVED EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333242 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1