BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3961167 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13581
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED TO START USING THERAPY AGAIN, SO THE HEALTHCARE PROVIDER (HCP) WAS CHECKING THE INTEGRITY OF THE PUMP AND THE CATHETER, AS IT HAD BEEN IN ¿STOPPED PUMP MODE¿ FOR 2 YEARS. THE HCP DID A DYE STUDY ON THE DAY OF THIS REPORT AND WAS UNABLE TO ASPIRATE. IT WAS NOTED THAT THE PHYSICIAN WAS ADVISED NOT TO PUT DYE IN, BUT HE CHOSE TO ANYWAY AND, WHEN HE DIDN¿T SEE ANY DYE, HE ASPIRATED RIGHT AWAY. THE HCP WAS GOING TO DISCUSS REPLACING THE PUMP AND CATHETER WITH THE PATIENT. THE REPORTER BELIEVED THAT THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE, BUT WAS NOT SURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439456 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR