BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2911072 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00481
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 19, 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
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# N179905006, IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE MOTOR STALLS OCCURRED AND WERE CONFIRMED BY TELEMETRY. PUMP LOGS SHOWED MOTOR STALLS ON (B)(6) ALL WITH RECOVERIES. THE MOTOR STALL ON (B)(6), ALSO SHOWED A TUBE SET MESSAGE PRIOR TO RECOVERY. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) DUE TO MENTAL STATUS CHANGES. AN MRI WAS PERFORMED "A COUPLE OF DAYS LATER". THERE WAS CONCERN THAT THE PUMP MAY HAVE BEEN CAUSING ENCEPHALOPATHY AND IT WAS BELIEVED THAT THE PATIENT HAD SUFFERED A STROKE. IT WAS NOTED THAT ON (B)(6), THE DOSE WAS DECREASED FROM MORPHINE 10MG/DAY TO 1.2MG/DAY, THEN LATER BACK UP TO 10MG/DAY. AT THE TIME OF THE REPORT, THE PATIENT WAS IN CRITICAL CONDITION AND WAS UNABLE TO COMMUNICATE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE 25MG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17350 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization