BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3872663 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11576
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 26, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THAT THE MANAGING HCP HAD NOT HAD ANY CONTACT WITH THE PATIENT SINCE LAST YEAR AND IT WAS LIKE "SHE JUST FELL OFF THE FACE OF THE EARTH:. THE REPORTER DIDN'T KNOW IF THE PATIENT WAS ABLE TO GET THE PUMP REFILLED OR ANY OTHER OUTCOME. ADDITIONAL INFORMATION LATER REPORTED THE PATIENT WAS EVALUATED ON (B)(6) 2013 WITH A LAST PUMP FILL DATE OF (B)(6) 2013. THE HCP WAS NOT SURE WHERE THE PATIENT WAS RECEIVING TREATMENT OR WHO WAS MAINTAINING THE PATIENT'S INTRATHECAL PUMP AS SHE WAS NO LONGER A PATIENT AT THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP STARTED BEEPING ¿A GOOD 2 DAYS AGO¿; TELEMETRY HAD NOT YET BEEN PERFORMED. THE PATIENT WAS OUT OF STATE TO BE WITH HER DYING FATHER WHO PASSED AWAY ON (B)(6) 2014. AS OF THE DATE OF THIS REPORT, THE PATIENT HAD BEEN YAWNING AND SWEATING REALLY BADLY; SHE REMEMBERED YAWNING THE DAY PRIOR AS WELL. THE PATIENT THOUGHT THAT IT WAS BECAUSE SHE HAD BEEN UP WITH HER FATHER. THE PATIENT WOULD BE BACK HOME IN 3-4 DAYS. THE PUMP HAD NOT BEEN REFILLED SINCE (B)(6) 2013; THE PATIENT STATED SHE ¿FORGOT ABOUT IT.¿ THE DEVICE SYSTEM WAS DELIVERING MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT WAS EXPERIENCING WITHDRAWAL. THE PATIENT STARTED HAVING SYMPTOMS ON (B)(6) 2014. AS OF (B)(6) 2014, THE PATIENT WAS ¿DEATHLY SICK¿, THROWING UP, AND CONVULSING. THE PATIENT HAD MISSED HER PUMP REFILL WHICH WAS SUPPOSED TO BE LAST WEEK. THE PATIENT WAS RETURNING TO HER HOME STATE THE EVENING OF (B)(6) 2014. THE PATIENT¿S PUMP WAS COMPLETELY EMPTY. THE PATIENT¿S MANAGING PHYSICIAN WAS UNABLE TO FILL THE PUMP UNTIL NEXT MONTH; THEY WERE LOOKING FOR ANOTHER PHYSICIAN THAT COULD REFILL THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349282 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other