BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3935881 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13037
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 25, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HIS DEVICE OR THERAPY AND WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT¿S LAST APPOINTMENT WAS NOTED AS (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PRESSURE IN HIS HEAD THAT WAS GETTING WORSE AND WORSE. IT WAS NOTED TO HAVE STARTED THREE DAYS PRIOR. THE PATIENT REPORTED THAT HE COULD NOT THINK AND WAS HAVING A HARD TIME CONVERSING. THE PATIENT REPORTEDLY FELT IT COULD BE AN INFECTION AND DID NOT WANT TO WAIT TOO LONG BEFORE SOMETHING BAD HAPPENS. THE PATIENT REPORTED THAT THE PRESSURE WAS STARTING AT THE BASE OF THE BRAIN WHERE THE SPINAL FLUID GOES UP IN TO THE BRAIN. IT WAS NOTED THAT THE PATIENT'S BOLUS WAS NOT WORKING AND THE PAIN WAS GONE BUT IT FELT LIKE IT WAS COMING BACK AGAIN. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP)WAS REPORTEDLY ON VACATION FOR THE NEXT TWO WEEKS BUT THE PATIENT WANTED A CT SCAN. THE PATIENT STATED THAT HE DIDN'T "KNOW WHY THEY WOULD PUT SOMETHING IN THE PUMP AND NOT TAKE CARE OF YOU". THE PATIENT REPORTEDLY FELT LIKE HE WAS HAVING A PANIC ATTACK. THE PATIENT'S PUMP WAS INTENDED TO INFUSE DILAUDID AND BUPIVACAINE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414316 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention