BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170983 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10415
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL, THOUGH THE REASON FOR WHICH WAS UNKNOWN. THE PHYSICIAN WAS INQUIRING ABOUT STOPPING THE PUMP WITH A MAGNET. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271379 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization