BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200736 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11144
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP ALARMED APPROXIMATELY 1 MONTH PRIOR TO THE REPORT. THE PATIENT PRESENTED TO A HEALTHCARE PROVIDER (HCP) APPROXIMATELY 1 WEEK FOLLOWING THE ALARM WHO STATED ¿WELL, THERE¿S STILL MEDICATION IN THE PUMP, BUT IT DOESN¿T SEEM TO BE WORKING RIGHT, ITS OK, WE¿LL LEAVE IT, WE¿LL WORRY ABOUT IT NEXT MONTH WHEN YOU COME IN FOR A REFILL¿. THE PATIENT¿S MANAGING PHYSICIAN HAD RETIRED SO THE HCP THAT THE PATIENT WENT TO WAS ¿COMPLETELY CLUELESS¿ WITH HOW THE DEVICE SYSTEM WORKED. THE CALLER STATED THAT THE PATIENT HAD BEEN WITHOUT MEDICATION FOR OVER A MONTH AND ¿IT IS NOT PUMPING MEDICATION INTO HER SYSTEM¿. THE CALLER STATED THAT THE PATIENT ¿HAS BEEN COMPLETELY WRITHING IN PAIN NOW FOR OVER THREE WEEKS¿ AND HAD NO FALLS OR TRAUMA. THE PATIENT WAS SCHEDULED FOR A PUMP REFILL ON (B)(6) 2013. THE HCP WANTED TO SCHEDULE THE PATIENT FOR AN MRI TO LOOK AT THE PUMP. THE PATIENT AND CALLER REQUESTED TO SEE A MORE EXPERIENCED HCP. THE DEVICE SYSTEM DELIVERED MORPHINE AND POSSIBLY FENTANYL ¿AT ONE POINT¿. IT WAS LATER REPORTED THAT THE ALARM WAS A CRITICAL ALARM AND WAS CURRENTLY GOING OFF EVERY 20 MINUTES. THE PATIENT WAS IN WRITHING PAIN AND DEVELOPED A NEW ¿RADIATING PAIN¿ ALONG BOTH SIDES OF HER SPINE THAT RADIATED FROM HER LOWER BACK UP INTO HER SHOULDERS. THE RADIATING PAIN BEGAN THE AFTERNOON PRIOR TO THE REPORT; HOWEVER, THE PATIENT HAD BEEN COMPLAINING ABOUT ¿A COUPLE THINGS THE LAST COUPLE OF DAYS¿. THE CALLER ALSO BELIEVED THE PATIENT MAY HAVE BEEN HAVING SOME WITHDRAWAL FROM THE MORPHINE. THE PATIENT HAD NOT FOLLOWED UP WITH THE HCP AND CONTINUED TO SEEK A MORE EXPERIENCED HCP TO MANAGE THE PUMP. THE CALLER WAS TO TAKE THE PATIENT TO THE EMERGENCY ROOM (ER). 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
    297288 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR