BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202366 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00126
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PERSONAL THERAPY MANAGER (PTM) DISPLAYED THE ERROR CODE 8286 EMPTY RESERVOIR OCCURRED. THE PATIENT WAS TO COME IN ON (B)(6) 2012 FOR A REFILL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DRUG IN THE PUMP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302980 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR