BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2920354 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00714
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REFILL THE TUESDAY PRIOR TO REPORT AND WAS COMPLAINING OF INCREASED PAIN. A DYE STUDY WAS DONE TWO DAYS LATER AND SHOWED THE CATHETER WAS IN PLACE WITH NO VISIBLE KINKS. THEREFORE, THE PHYSICIAN BELIEVED EVERYTHING WAS "CORRECT." THAT NIGHT THE PATIENT WAS WEAK, SHAKY, AND DIZZY AND WENT TO SLEEP. THE FOLLOWING MORNING THEY WERE UNABLE TO WAKE THE PATIENT AND SHE HAD SHALLOW BREATHING. IT WAS AS IF THE PATIENT "WAS SLIPPING INTO A COMA." THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. IT HAD BEEN SUSPECTED THE PATIENT HAD A STROKE; HOWEVER, STROKE WAS RULED OUT. THE PHYSICIAN SUSPECTED THE PATIENT WAS GIVEN TOO MUCH MEDICATION. THE PATIENT WAS DOING MUCH BETTER AS OF (B)(6) 2012. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26560 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other