BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3002016 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03636
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD OVERDOSED RIGHT AFTER THEY WERE IMPLANTED "ABOUT FIVE YEARS" AGO IN 2009. THE PATIENT CONFIRMED HAVING HALLUCINATIONS AND STATED THAT THEY WERE SEEING THINGS, SWEATING PROFUSELY; THAT THEY WERE DIZZY, NOT ABLE TO THINK CLEARLY, NOT ABLE TO READ; THAT THEY BARELY FUNCTIONED; THAT THEIR BEHAVIOR WAS ERRATIC IN THE LAST FIVE YEARS. THE PATIENT FURTHER STATED THAT THEY HAD BEEN IN BED AND THROWING UP FOR EIGHT WEEKS AND NOTED THIS HAD HAPPENED "ABOUT FOUR OR FIVE TIMES". THE LAST TIME IT HAPPENED WAS IN (B)(6) 2011. THE PATIENT FURTHER STATED THAT "SHE WAS JUST LITERALLY DYING," BUT THE PATIENT'S PHYSICIAN DID NOT THINK ANYTHING WAS WRONG. THE PATIENT WAS GIVEN NAUSEA MEDICATION, PROMETHAZINE, AND CODEINE. THE PATIENT HAD NOT YET TAKEN THE CODEINE, AND ANTICIPATED USING IT IF WITHDRAWAL SYMPTOMS APPEARED. THE PATIENT STATED THAT THEIR MEDICATION WAS TURNED DOWN "25 AND 25," AND FURTHER STATED THAT THEY WERE DOWN 70 OR 80 PERCENT. THE PATIENT WAS NOT CERTAIN ABOUT "HOW TO MEASURE IT". THE PATIENT WAS NOTED TO HAVE HAD HIGH BLOOD PRESSURE AND WAS PUT ON "HIGH BLOOD PRESSURE PILLS" THAT PARALYZED HER LEGS TWO SEPARATE TIMES. THE PATIENT STATED, SHE COULD NOT WALK. THIS WAS THOUGHT TO HAVE RESOLVED AS OF THE DATE OF THIS REPORT. THE PATIENT WAS ALSO PRESCRIBED "FOUR BARS OF XANAX A DAY," IN ADDITION TO "SOME OTHER MUSCLE RELAXERS". AS OF THE DATE OF THIS REPORT, THE PATIENT STATED THAT THEY WERE STARTING TO THINK CLEARLY. THE MEDICATION USED WITHIN THE SYSTEM WAS FENTANYL. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104625 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other