BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2834395 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10338
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 16, 2012
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J10896R28, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT OVERDOSED AFTER A REFILL. IT WAS INDICATED ON (B)(6) 2012 DURING A REFILL THAT "A WEIRD INCIDENT HAPPENED," AS THE NURSE HAD PULLED OUT EVERYTHING OUT OF THE PUMP. IT WAS STATED THAT 4.1CC'S "OR SOMETHING LIKE THAT" WAS PULLED OUT AND THE PATIENT NOTICED SEEING ABOUT 2CC'S OF BROWN COLORED FLUID. THE PORT WAS FLUSHED WITH SALINE AND BROWN FLUID WAS PULLED OUT AGAIN. THIS HAPPENED A THIRD TIME AS THE PHYSICIAN HAD FLUSHED WITH SALINE AND PULLED OUT THE COLORED FLUID THIS TIME. IT WAS REPORTED THAT THE PHYSICIAN SENT THE SYRINGE WITH THE BROWN FLUID TO LAB FOR TESTING. AFTER THE REFILL, THE PATIENT EXPERIENCED AN OVER DOSE. IT WAS STATED THAT HE WAS "OUT OF HIS MIND" AND WAS NOT ABLE TO SWALLOW. IT WAS INDICATED THAT THE PATIENT STARTED TO FEEL BETTER AND WENT TO GET SOMETHING TO EAT, BUT WHILE THERE "HE WAS SO DRUGGED" THAT HE PASSED OUT. HE ENDED UP DRIVING HOME "THAT MESSED UP," AND THEN PASSED OUT IN THE CAR WHILE IT WAS RUNNING. THE FOLLOWING DAY, THE PATIENT COULD "HARDLY FUNCTION." THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE PATIENT GETS REFILLS ABOUT EVERY 3 MONTHS. THE DRUGS DELIVERED VIA PUMP WERE HYDROMORPHONE AND CLONIDINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FELT DIZZY AFTER GETTING UP FOLLOWING THE REFILL. IT WAS REPORTED ON 2013-(B)(6) THE PATIENT WAS STILL HAVING CONCERNS ABOUT THE DEVICE OR THERAPY REGARDING THE BROWN FLUID WITHDRAWN FROM THE PUMP. THE FLUID WAS ALWAYS THE LAST FLUID IN THE SYRINGE AND HAS NEVER BEEN NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other