BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162257 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10135
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 22, 2013
    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 MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SECOND PUMP WAS NOT WORKING PROPERLY AFTER A YEAR IT ¿KEPT CLOGGING¿. IT WAS REPORTED THE WHOLE SYSTEM WAS REPLACED. IT WAS LATER REPORTED THAT PATIENT HAD THE SIDE PORT CHECKED AND THERE WAS NO FLOW. THE PUMP WAS NEAR END OF LIFE AND CATHETER WAS OCCLUDED. TOTAL INFUSION SYSTEM WAS EXPLANTED ON 07/18/2011. THE OUTCOME WAS INDICATED AS ¿NO INJURY¿.THE PUMP WAS BEING USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263032 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention