BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3073186 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06771
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L65391, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE CATHETER HAD BEEN IMPLANTED FOR QUITE A WHILE AND THE HCP THOUGHT IT MAY NEED TO BE REPLACED. THE PATIENT HAD NO COMPLAINTS ABOUT HER PUMP. THE DRUG DELIVERED BY THE PUMP WAS BELIEVED TO BE MORPHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DYE STUDY WAS BEING PERFORMED, AND THE PATIENT'S HEALTHCARE PROVIDERS WERE CONCERNED THE PATIENT MIGHT HAVE AN INFLAMMATORY MASS. IT WAS FURTHER NOTED THAT THE PATIENT HAD NO COMPLAINTS, BUT A DYE STUDY WAS BEING PERFORMED. THE REASON FOR THE DYE STUDY WAS NOT KNOWN AT THE TIME OF THE REPORT. DURING THE DYE STUDY, IT WAS REVEALED THAT 'THEY COULD NOT ASPIRATE' AND THE POSSIBILITY OF AN INFLAMMATORY MASS WAS MENTIONED. THE PATIENT WAS NOTED TO BE ASYMPTOMATIC AND WAS 'FINE' AND 'HAPPY.' THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173691 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other