BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3221483 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11636
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STATED THE PUMP WAS NOT WORKING. AN MRI WAS PLANNED.THE PATIENT HAS "AIR ON HER BRAIN" AND THEY SUSPECT SHE MAY BE INJECTING HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319709 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR