BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3241360 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12117
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 29, 2013
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8731 LOT# SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS ON THE MORNING OF THE REPORT DATE AND WAS TAKEN TO THE EMERGENCY ROOM WITH A VERY LOW BLOOD PRESSURE AND ALTERED MENTAL STATUS. THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI) AND THE PUMP WAS PROGRAMED TO MINIMUM RATE. THE PATIENT WAS ADMINISTERED NARCAN FOUR TIMES AND BECAME RESPONSIVE FOR ¿MOMENTS¿ PER THE NURSE. THE PATIENT THEN BECAME LESS AND LESS RESPONSIVE AS THE DAY PROGRESSED; NOREPINEPHRINE WAS USED TO HELP WITH THE BLOOD PRESSURE, ANTIBIOTICS (CIPRO) WAS INITIALLY USED FOR THE UTI BUT THE PATIENT DEVELOPED A RED PATCH SHORTLY AFTER ADMINISTRATION SO IT WAS STOPPED AND THE ICU (INTENSIVE CARE UNIT) BELIEVED THE PATIENT ¿MAY BE¿ SEPTIC. IT WAS NOTED THE DEVICE SYSTEM HAD BEEN REPLACED THE PREVIOUS DAY AND HAD BEEN PROGRAMMED TO DELIVER THE SAME MEDICATIONS AND DAILY DOSE AS THE PREVIOUS PUMP. IT WAS REPORTED DURING THE REPLACEMENT SURGERY, THE OLD CATHETER BROKE AS THE HEALTH CARE PROVIDER (HCP) WAS EXPLANTING IT. AS A RESULT A PART OF THE OLD CATHETER REMAINS IN THE PATIENT¿S CEREBROSPINAL FLUID. AS A RESULT OF THE EVENT, THE PATIENT WAS HOSPITALIZED AND THE DEVICE WAS REPROGRAMMED. DIAGNOSTIC TESTING/TROUBLESHOOTING HAD NOT YET BEEN PERFORMED BUT WAS TO BE IN THE FUTURE. X-RAYS WERE RECOMMENDED TO DETERMINE THAT THE CATHETER HAD NOT MIGRATED. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN AND DILAUDID. IT WAS LATER REPORTED NO ADDITIONAL TROUBLESHOOTING WAS DONE AND THE PUMP REMAINED ON MINIMUM RATE. THE PATIENT WAS REPORTEDLY DOING ¿BETTER MEANING SHE WAS BEING TAKEN OFF DRIPS¿ THAT EVENING. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340330 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R