BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203483 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11213
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S KIDNEYS SHUT DOWN, SO THEY HAD TO TURN THE PUMP DOWN AND FOR A TIME, THE PATIENT WASN¿T ALLOWED ANY BOLUSES WITH HER PTM (PERSONAL THERAPY MANAGER). THE PATIENT¿S KIDNEYS GOT BETTER/WENT BACK TO 100%, SO THE PATIENT WAS AGAIN ALLOWED TO USE HER PTM. THE PUMP WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302764 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention