BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3951231 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13388
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    April 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A NEW PUMP IMPLANTED BECAUSE THEIR OLD PUMP WAS NOT COMPATIBLE WITH THE PERSONAL THERAPY MANAGER (PTM). THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) WANTED HER TO HAVE A PTM SO HE REPLACED THE PUMP. IT WAS NOTED THERE WAS STERILE MORPHINE IN THE PUMP THAT WAS 6 MONTHS OLD SO THEY PUT IT IN THE NEW PUMP. THE DRUG WAS GOLDEN IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427859 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR