BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1162786 · Received September 16, 2008

    Report

    Report Number
    6000030-2008-05777
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 1, 2007
    Report Date
    August 18, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SINCE APPROXIMATELY 2007, ONE DAY BEFORE THE PATIENT'S REFILL IS DUE SHE EXPERIENCES ELECTRICAL SHOCKS TO HER HEAD, THINGS GO BLACK, HER LEGS ARE WEAK, SHE DOES NOT FEEL WELL, SHE HAS SHOCKS OF PAIN, AND HER EYES ROLL. THE LAST TIME SHE HAD THE EVENT IT WAS AT HEART LEVEL. SHE HAD MENTIONED IT TO HER NEUROSURGEON AND THE EMERGENCY ROOM AND WAS TOLD THAT IT WAS WARNING SIGNS OF A HEADACHE. SHE STATED THAT THIS IS WHAT WAS DOCUMENTED IN HER FILE. AT HER PUMP REFILL, THEY TOLD HER THAT WHEN SHE NOTICED THE ELECTRICAL SHOCKS, IT WAS BECAUSE SHE WAS GOING TO HAVE A HEADACHE. THE PATIENT DIDN'T BELIEVE THAT THIS WAS THE CASE. WHEN SHE HAS THE ELECTRICAL SHOCKS AT NIGHT, THE NEXT DAY SHE IS "AS SICK AS A DOG" AND IT TAKES ABOUT 30 HOURS BEFORE EVERYTHING IS BACK TO NORMAL. THE PATIENT WAS WONDERING IF IT WAS WITHDRAWALS, BUT WHEN SHE GOES TO THE HOSPITAL, SHE LOOKS LIKE A "NARCOMANE". SHE SPOKE TO TWO PHARMACISTS AND THEY TOLD THE PATIENT THAT IT COULD BE THE MORPHINE. THE PATIENT BELIEVES HER SYMPTOMS ARE DUE TO MORPHINE. AT THE END OF HER CYCLE SHE YAWNS A LOT AND SHE THOUGHT THIS COULD BE A SYMPTOM OF WITHDRAWAL. HER PUMP REFILLS HAD BEEN EVERY 3 WEEKS, BUT THEY WERE CHANGING THEM TO EVERY 10 DAYS. THE INCREASED FREQUENCY OF THE REFILLS DID RESOLVE THE PATIENT'S ISSUES FOR A WHILE. AS OF 2008, THEY WERE WEANING THE PATIENT OFF THE MEDICATION AND REDUCING THE CONCENTRATION. THEY WERE EVALUATING THE PUMP/CATHETER AND MEDICATION. THEY WERE CONSIDERING USING A DIFFERENT DRUG COMBINATION WHEN THEY CONFIRM THAT "ALL IN GOOD ORDER". SEE MANUFACTURER'S REPORT # 2182207200801942.

    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 Required Intervention CATHETER MODEL 8709 LOT# UNKNOWN IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT #UNKNOWN