BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3931912 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12961
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT# J0039925R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS ¿SHOWING SIGNS OF EROSION¿ THROUGH THE SKIN. THE PUMP WAS REPLACED AND THE NEW PUMP WAS PLACED APPROXIMATELY HALF AN INCH UNDER THE MUSCLE TO PREVENT EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411114 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention