BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3103089 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07458
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS WITH A FEVER OF 108 DEGREES. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) WHERE THEY WERE HOSPITALIZED AND INTUBATED. IT WAS SUSPECTED THE PATIENT HAD HEAT STROKE. THE PATIENT ALSO HAD AN ALTERED MENTAL STATUS, SWEATING AND UNDERDOSE SYMPTOMS. THE PUMP SYSTEM WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN. IT WAS LATER REPORTED THAT NO TROUBLESHOOTING WAS DONE. THE PATIENT WAS RECOVERING AND WAS GETTING BENEFIT FROM THE THERAPY. IT WAS AGAIN NOTED THAT IT WAS THOUGHT THAT THE PATIENT HAD HEAT STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203647 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R