BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2082965 · Received May 4, 2011

    Report

    Report Number
    6000030-2011-03236
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    November 15, 2006
    Report Date
    April 19, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 THE PT HAD NOT BEEN DOING SO WELL. A PHYSICIAN WANTED TO TRY A LOWER CONCENTRATION. THE PUMP CONTAINED LIORESAL 2000 MCG/ML; THE NEW CONCENTRATION WAS 500 MCG/ML. ON (B)(6) 2011, ADDITIONAL INFO WAS RECEIVED. A PUMP WAS EXPLANTED IN (B)(6) 2006 DUE TO A PUMP SITE INFECTION; AND WAS LATER REPLACED IN (B)(6) 2006. SINCE THAT TIME, THE PT HAS NOT BEEN SPASTICITY CONTROL DESPITE DOSE INCREASES. THE ENTIRE PUMP SYSTEM WAS REPLACED IN (B)(6) 2010 WITHOUT IMPROVEMENT. IT WAS NOTED THAT THE PT USED TO HAVE GOOD CONTROL OF SPASTICITY. MULTIPLE INTERVENTIONS HAVE BEEN TRIED: THE DOSE HAD BEEN INCREASED FROM 300 - 671, THE CONCENTRATION OF LIORESAL WAS CHANGED FROM 2000MCG/ML TO 500MCG/ML AS WELL AS TRYING AN EVERY 6 HOUR BOLUS. THE HEALTHCARE PROVIDER INDICATED THAT THERE WAS NO CAUSE FOUND; AND HE BELIEVED THIS WAS "THERAPY FAILURE NOT A DEVICE FAILURE". PER THE REPORTER, THERE WAS A "2ND OPINION IN BOSTON". THE PT OUTCOME WAS "NO INJURY". ON (B)(6) 2011, IT WAS FURTHER REPORTED THAT THE PHYSICIAN WANTED TO RETURN BACK TO USING 2000 MCG/ML OF LIORESAL, AND TRYING FLEX DOSING. ADDITIONAL INFO 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 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| LOT# NGV438662H| EXPLANTED:| CATHETER: MODEL 8709, LOT# J0177977R| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N166934009| CATHETER: MODEL 8709SC, LOT# N256557003| CATHETER: MODEL 8709, LOT# N080554011| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740,| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40,| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NGV020536N