BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4147808 · Received October 7, 2014

    Report

    Report Number
    3004209178-2014-18413
    Event Type
    Injury
    Date Received
    October 7, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS BEING USED TO DELIVER BUPIVACAINE AND MORPHINE. PATIENT OUTCOME WAS NOT REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ASKED THE HEALTHCARE PROVIDER (HCP) TO TURN THE PUMP DOWN BECAUSE THEY WERE TOLD THEIR LIVER WAS SHOOTING OFF ENZYMES. THE PATIENT TRIED TO COMMIT SUICIDE BECAUSE OF EVERYTHING, NOTING SHE ALMOST TRIED TO KILL HERSELF BECAUSE OF THIS PUMP. THE PATIENT¿S VISION AND VOICE HAD CHANGED, AND THEY HAVE BEEN SO DEPRESSED. THE MEDICATION IN THE PUMP AT THE TIME OF THE EVENT WAS UNKNOWN. NO OUTCOME OR PUMP MEDICATIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627105 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Other