BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202372 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-03866
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS READ BEFORE IMPLANT AND SHOWED A MOTOR STALL. THE PUMP WAS IN SHELF STATE. THE PUMP WAS NOT ALARMING. THE PUMP WAS NOT IMPLANTED AND ANOTHER PUMP WAS IMPLANTED. THE PUMP WAS SENT BACK TO THE MANUFACTURER. THE PREVIOUS PUMP WAS BEING REPLACED FOR NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302982 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other