BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3811412 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08995
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONCE A MONTH FOR THE PAST YEAR THE PUMP STOPPED WORKING FOR THE PATIENT, MOST RECENTLY ON (B)(6) 2014. THE PATIENT HAD WITHDRAWAL AND AN INCREASE IN PAIN. THE LOGS APPEARED NORMAL. NO STALLS OR INDICATIONS THAT THE PUMP HAD STOPPED WERE SEEN. IT WAS UNKNOWN IF THERE HAD BEEN ANY HISTORICAL VOLUME DISCREPANCIES, BUT AT THE LAST REFILL ON (B)(6) 2014 THE EXPECTED VOLUME WAS 16.9 MILLILITERS (ML) AND THE ACTUAL VOLUME WAS 16 ML. IT WAS NOTED THE PATIENT SYMPTOMS DID NOT CORRELATE WITH THE REFILL CYCLE. THE SYSTEM WAS BEING USED TO DELIVER FENTANYL AND HAD PREVIOUSLY BEEN USED TO DELIVER DILAUDID AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292097 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR