BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3032652 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04525
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    May 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOT LONG AFTER THIS PUMP WAS IMPLANTED THE PATIENT HAD THOUGHT PERHAPS THE PUMP WAS NOT WORKING AS SHE FELT TERRIBLE PAIN. THE PATIENT HAD REQUESTED THE PUMP BE INCREASED WHICH SHE REPORTED IT HAD BUT THIS HAD NOT PROVIDED MUCH RELIEF. AFTER PUMP REFILLS, THE PATIENT DID NOT FEEL RELIEF AS THE PAIN REMAINED CONSTANT. THE PATIENT HAD INQUIRED IF AT THAT TIME PERHAPS THE MEDICINE WAS NOT BEING DELIVERED TO THE APPROPRIATE SPOT. THE PATIENT HAD FRACTURED HER PELVIS AND AN X-RAY WAS TAKEN IN (B)(6) 2012 WHICH REVEALED THAT THE CATHETER WAS "OUT OF MY SPINE" AND WRAPPED AROUND THE PUMP IN A "BALL THING." THE MONTH PRIOR TO THIS REPORT THE PHYSICIAN HAD ASPIRATED THE REMAINING MORPHINE THAT WAS IN THE PUMP AND REPLACED IT WITH SALINE. THE PATIENT WAS PROVIDED WITH ORAL MEDICATION FOR PAIN RELIEF UNTIL THE SCHEDULED REVISION. HOWEVER, THE REVISION WAS DELAYED DUE TO A HIGH WHITE BLOOD CELL COUNT. AS A RESULT, THE PATIENT WAS TO FOLLOW UP WITH A HEMATOLOGIST TO FURTHER ADDRESS THIS ISSUE. THE PATIENT WAS CONCERNED SHE WOULD NOT HAVE ENOUGH ORAL MEDICATION AND THAT THE PUMP WOULD BE EMPTY BY THE TIME THE REVISION COULD TAKE PLACE. THE PATIENT WAS CONCERNED REGARDING THE CARE SHE RECEIVED. THIS DEVICE SYSTEM HAD DELIVERED MORPHINE UNTIL THE RECENT CHANGE TO SALINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WERE NO ISSUES FOUND WITH THE PUMP. THE CATHETER REVISION WAS PLANNED BECAUSE THERE WAS NO INDICATION OF AN ISSUE WITH THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT HADN¿T HAD SURGERY TO CORRECT THE CATHETER ISSUE AS AT THIS SAME TIME THE PATIENT HAD OTHER HEALTH PROBLEMS DIAGNOSED. AS A RESULT THE PATIENT REPORTED THAT THEY DECIDED TO GO ANOTHER WAY. THE PATIENT INDICATED THAT THEY WOULD CALL THE HCP.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE CATHETER HAD BECOME DISLODGED AND WAS NOT COILED. THIS DETERMINATION WAS MADE RIGHT BEFORE (B)(6) 2012. THE PATIENT HAD A LOT OF ISSUES FINANCIALLY AND OTHERWISE AND THE PATIENT CANCELED HER CATHETER REVISION. THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2013 AT WHICH TIME A BRIDGE BOLUS WAS PERFORMED TO DEPLETE THE MORPHINE FROM THE LINE. THE BRIDGE BOLUS WAS GOING TO TAKE 59 HOURS AND 54 MINUTES TO COMPLETE. PFNS WAS FILLED IN THE PUMP JUST TO KEEP IT FROM BEING DRY. THERE WAS NO NOTE THAT A PUMP RINSE HAD BEEN DONE. THE PATIENT WAS TOLD SHE REALLY NEEDED TO HAVE THE SURGERY AND COULD NOT CONTINUE PUMP THERAPY WITHOUT IT. THE HCP HAD NOT HEARD FROM THE PATIENT SINCE (B)(6) 2013. THE HCP AND THE SURGEON'S OFFICE HAD CALLED THE PATIENT AND THEY WERE UNABLE TO GET THE PATIENT TO RESPOND TO THE PHONE CALLS OR LETTERS. THE PATIENT¿S CURRENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136750 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention