BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3094012 · Received May 6, 2013

    Report

    Report Number
    3004209178-2013-07330
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# J0058181R, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS ¿PURELY A SCHEDULING ISSUE,¿ THERE WAS NO DEVICE ISSUE AT ALL, THE DEVICE WAS WORKING ¿WELL.¿ THE PATIENT WAS REFILLED, REFILL DATE WAS NOT KNOWN, AND WAS DOING WELL. IT WAS NOTED THAT THE PATIENT ¿ALWAYS BYPASSES THE PHYSICIAN¿S OFFICE AND GOES TO THE EMERGENCY ROOM.¿ ¿THEY CALL HIM A FREQUENT FLYER.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD COME INTO THE EMERGENCY ROOM (ER) EXPERIENCING "ALTERED MENTAL STATUS" AND HAD A SEIZURE. IT WAS FOUND THAT THE LOW RESERVOIR ALARM DATE WAS (B)(6) 2013. IT WAS STATED THAT THE PATIENT WAS LIKELY EXPERIENCING BACLOFEN WITHDRAWAL AND THERE WOULD MOST LIKELY NOT BE ENOUGH DRUG IN THE PUMP TO LAST A FEW DAYS. THE PATIENT WAS ALSO EXPERIENCING HIGH BLOOD PRESSURE, PAIN, RETURN OF SEVERE BACK SPASMS, AND THE BEGINNING STAGES OF "RHABDO". THE PATIENT HAD A SECOND SEIZURE WHILE TRAVELING FROM THE ER TO THE CRITICAL CARE UNIT (CCU). AT THAT TIME, THE PATIENT "CODED" AND WAS INTUBATED. THE PATIENT WAS ALSO GIVEN "SEVERAL MEDICATIONS TO HELP STABILIZE HIM." IT WAS FOUND THAT THE RESERVOIR ONLY CONTAINED 1.1ML OF DRUG. THE PATIENT WAS PUT ON VALIUM TO MANAGE THE WITHDRAWALS AND A REFILL WAS PERFORMED THAT NIGHT. ON THE MORNING AFTER THE PATIENT WAS DOING BETTER, HE WAS RESPONSIVE, HIS BLOOD PRESSURE WAS NORMAL, AND HIS "CK" WAS GOING DOWN. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN AND INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196291 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| O| R