BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090147 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17036
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 21, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 4 DAYS AFTER IMPLANT, THE PATIENT STARTED HAVING PROBLEMS. THE PATIENT¿S MORPHINE WAS CUT OFF WITHIN 2 WEEKS, SO THE PATIENT HAD NO MORPHINE IN HER. THE PATIENT HAD BEEN LEAKING CEREBROSPINAL FLUID (CSF) FOR 3 WEEKS FOLLOWING IMPLANT. THE PATIENT¿S DEVICE WAS DEFECTIVE. THE PATIENT WAS HAVING PSYCHOLOGICAL PROBLEMS AND KEPT PASSING OUT. THE PATIENT HAD TO BE IN A REHABILITATION UNIT FOR 10 DAYS. THEY INITIALLY THOUGHT THAT THE PATIENT WAS ¿CRAZY¿. THE PATIENT WENT TO THE HOSPITAL 3 WEEKS LATER AND, AFTER BLOOD WORK WAS DONE AND AN X-RAY WAS TAKEN, IT WAS REALIZED THAT THE PATIENT HAD CEREBROSPINAL FLUID (CSF) IN HER BLOOD. THE PATIENT ALSO EXPERIENCED AN INFECTION AND WITHDRAWAL. THE DEVICE WAS ¿FAULTY¿. EMERGENCY SURGERY WAS DONE AND THE PUMP WAS REMOVED, AS IT COULDN¿T BE REUSED. BY THAT TIME, THE PATIENT HAD LOST APPROXIMATELY 25 POUNDS. AT THE TIME OF THIS REPORT, THE PATIENT WAS LOOKING FOR A NEW DOCTOR TO IMPLANT ANOTHER DEVICE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE PATIENT¿S MEDICAL STATUS PRIOR TO THE EVENT, SPECIFIC DEVICE ISSUES, CAUSE OF THE EVENT, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569630 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| L| R