BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3173731 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10474
    Event Type
    Injury
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# N189572014, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC THE WEEK PRIOR TO THE REPORT FOR A ROUTINE PUMP REFILL. LATER THAT DAY, THE PATIENT CAME BACK TO OFFICE WITH COMPLAINTS OF "LEAKING" FROM THE PUMP POCKET ONTO HER CLOTHES. THE HEALTHCARE PROVIDER (HCP) WAS CONCERNED THERE WAS A POCKET FILL, SO HE ASPIRATED THE POCKET AND WAS ABLE TO PULL OUT APPROXIMATELY 20ML OF FLUID. HE THEN TRIED TO ASPIRATE THE DRUG FROM RESERVOIR OF PUMP AND WAS ABLE TO PULL ALL OF THE DRUG THAT HAD JUST BEEN FILLED. IT WAS DETERMINED THAT THE FLUID IN THE POCKET MUST HAVE BEEN CEREBROSPINAL FLUID (CSF). THE PUMP WAS PROGRAMMED TO SLOWEST PROGRAMMABLE RATE AND A REVISION WAS SCHEDULED. A ¿CATHETER GRAM¿ WAS ALSO PERFORMED AND THE HCP SAW DYE IN THE POCKET. THE REVISION OCCURRED ON THE DAY OF THE REPORT. WHEN THE HCP PULLED THE PUMP FROM THE POCKET, IT WAS OBSERVED THAT THE CATHETER WAS STILL CONNECTED TO PUMP VIA THE SUTURELESS CONNECTION (SC), BUT THE CLEAR BOOT WAS PULLED BACK. THE HCP THEN ALSO NOTED A DRIPPING FROM CATHETER AT A SMALL TEAR APPROXIMATELY 14CM FROM THE END OF CATHETER. THE HCP REMOVED THE SC, CUT THE CATHETER 15 CM AND RECONNECTED A NEW SC CATHETER. A NEW PUMP WAS ALSO IMPLANTED SINCE HER CURRENT PUMP WAS MORE THAN 4 YEARS OLD. ALL NEW CONNECTIONS PROVIDED GOOD CSF FLOW. IT WAS NOTED THAT THE PATIENT HAD REPORTED MULTIPLE FALLS WHICH THE HCP BELIEVED MAY HAVE CAUSED THE TEAR IN THE CATHETER. THE PATIENT WAS REPORTED TO HAVE BEEN DOING FINE POST OPERATION. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274049 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention