BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2093004 · Received May 3, 2011

    Report

    Report Number
    6000030-2011-03217
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS INITIALLY REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL FOR BACK PAIN. THE PATIENT HAD/WAS TO RECEIVE AN MRI DUE TO THE BACK PAIN. ON (B)(6) 2011, IT WAS LATER REPORTED THAT THE PATIENT HAD VISITED A PHYSICIAN ON (B)(6) 2011 FOR A PUMP DYE STUDY. THE PATIENT HAD AN ABRUPT DECREASE OF HER ANALGESIA, AND THE PATIENT WAS WONDERING IF THE CATHETER WAS IN THE RIGHT PLACE. ASPIRATION OF 2 ML OF CSF WAS ACHIEVED, HOWEVER, IT WAS NOTED THE CSF RETURNED EXTREMELY SLOWLY. THE CATHETER WAS SEEN TO BE INTACT, AND WAS SEEN TO ENTER INTO THE SPINE AT ABOUT THE T12-L1 LEVEL. THE CATHETER HAD PROGRESSED UP THE INTRATHECAL SPACE, AND COULD BE OBSERVED TRACKING POSTERIORLY. INJECTION OF CONTRAST WENT SMOOTHLY. THE INJECTION OF CONTRAST ON THE AP VIEWS WERE SEEN TO BE IN THE CENTER OF THE SPINE. ON THE LATERAL VIEWS IT APPEARED THAT THE CONTRAST WAS LAYERING POSTERIORLY, AND WHAT APPEARED TO BE THE EPIDURAL SPACE. ASPIRATION THEN OF FURTHER CSF WAS SOMEWHAT DIFFICULT AND WAS INTERMITTENT. THE PHYSICIAN BELIEVED THE CATHETER WAS PARTIALLY IN THE EPIDURAL SPACE, AND PARTIALLY IN THE INTRATHECAL SPACE. IT WAS BELIEVED THAT THIS WOULD ACCOUNT FOR SOME OF THE INTERMITTENT LOSS OF ANALGESIA. THE PUMP WAS THEN REPROGRAMMED. THE DRUG ADMINISTERED VIA THE PUMP WAS MORPHINE. THE PATIENT WAS NOTED AS HAVING BEEN GIVEN A DOSE OF 10.5 MG/DAY FROM A CONCENTRATION OF 30 MG/DAY; AND WAS GIVEN A BOLUS OF 10 MG TO FLUSH THE FLUIDS THROUGH THE PUMP. THE PHYSICIAN DISCUSSED REPLACING THE CATHETER, HOWEVER, THE PATIENT WANTED TO LEAVE IT THE WAY IT WAS AT THAT TIME. THE BATTERY WAS NOTED AS BEING ABOUT 8 YEARS OLD AND PROBABLY CLOSE TO ITS END OF LIFE. THE PHYSICIAN WILL CONSIDER REPLACING THE CATHETER AND THE PUMP IN THE FUTURE. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR CATHETER: MODEL 8709, LOT# J11586R25| EXPLANTED:| IMPLANTED: