BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3173734 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10464
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 23, 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

    CONCOMITANT PRODUCT: 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 OUT OF STATE AND MISSED A REFILL APPOINTMENT. THE PATIENT HAD PLANNED TO BE OUT OF STATED FOR 6 WEEKS BUT BY THE TIME OF THE REPORT HAD BEEN OUT OF STATE FOR 3 MONTHS. THE PATIENT LAST HAD A PUMP REFILL AT THE END OF (B)(6), 2013 AND HAD BEEN DUE FOR ANOTHER REFILL AT THE END OF (B)(6) 2013. THE CALLER BELIEVED THE PUMP WAS CURRENTLY EMPTY AND HAD BEEN HEARING A CRITICAL ALARM. THE PATIENT BEGAN EXPERIENCING WITHDRAWAL SYMPTOMS AND ¿FEELING VERY SICK¿ APPROXIMATELY 5-7 DAYS PRIOR TO THE REPORT. THE PATIENT WAS PLANNING ON RETURNING HOME ON (B)(6) 2013 BUT THE CALLER WAS SEEKING A PHYSICIAN TO EITHER REFILL THE PUMP OR PROVIDE THE PATIENT WITH ORAL MEDICATION TO COVER FOR THE EMPTY PUMP UNTIL THEN. THE DEVICE SYSTEM WAS USED TO DELIVER ¿SOME TYPE OF MORPHINE¿. THE CALLER STATED THAT THE DEVICE DELIVERED ANOTHER MEDICATION BUT WAS UNSURE WHAT THE MEDICATION WAS. IT WAS LATER REPORTED THAT THE PUMP HAD RUN OUT OF MEDICATION 3 WEEKS PRIOR TO THE REPORT AND THE PATIENT WAS GOING THROUGH WITHDRAWALS. THE PATIENT WAS ON THEIR WAY TO THE EMERGENCY ROOM (ER). THE CALLER STATED THAT THE PUMP WAS A ¿PAIN PUMP¿ BUT DID NOT KNOW WHAT MEDICATION HAD BEEN DELIVERED BY THE DEVICE SYSTEM. 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
    274050 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR