BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2993273 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03461
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL DUE TO BEING IN THE "ICU". THE PATIENT WAS IN THE ICU ON (B)(6) 2012 AND AGAIN ON (B)(6) 2013. THE PATIENT HAD A BREATHING EDEMA AND WAS IN A LONG TERM CARE FACILITY. IT WAS REPORTED THAT THE PATIENT "DIDN'T HAVE ENOUGH OXYGEN TO HER BRAIN SO THE THREE SEGMENTS OF HER BODY THAT ARE SUPPOSED TO ADHERE TO RECOGNITION, ET CETERA, IS NOT WORKING". THE PATIENT IS NOT AWAKE OR HAS NOT RESPONDED TO "ANY OF THE THINGS". IT WAS ALSO REPORTED THAT "SHE IS IN A SLEEP MODE NOW" AND IF SHE SHOULD HAPPEN TO WAKE DURING THE ALARM SHE "MIGHT HAVE ANOTHER CARDIAC ARREST". THE PATIENT'S REFILL ALARM WAS SCHEDULED TO ALARM THE DAY BEFORE THE REPORT BUT IT WAS UNKNOWN IF THE ALARM HAD GONE OFF. THE PUMP WAS INFUSING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97111 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization