BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4170532 · Received October 14, 2014

    Report

    Report Number
    3004209178-2014-19652
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 29, 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
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE DISCREPANCY WAS UNKNOWN. TROUBLESHOOTING INCLUDED AN X-RAY AND CT STUDY. AT THE TIME OF REPORT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VOLUME DISCREPANCIES WHERE THE ACTUAL RESIDUAL VOLUMES (ARVS) WERE GREATER THAN THE EXPECTED RESIDUAL VOLUMES (ERVS) OCCURRED; THE ARV AND ERV WERE 10 ML AND 2.9 ML, RESPECTIVELY, AT A REFILL APPOINTMENT ON (B)(6) 2014, AND THE ARV AND ERV WERE 19 ML AND 3.7 ML, RESPECTIVELY, ON (B)(6) 2014. THE PATIENT REPORTEDLY HAD EHLERS-DANLOS SYNDROME AND WAS ALWAYS IN A LOT OF PAIN, BUT HAD BEEN IN A LOT MORE PAIN FOR THE LAST 3 MONTHS. THE PAIN WAS SO INTENSE THAT THE PATIENT COULDN¿T PERFORM HER KEGEL EXERCISES. THE EVENT LOGS WERE CHECKED AND NO ISSUES WERE FOUND. NO PATIENT OUTCOME WAS REPORTED. THE PUMP WAS DELIVERING CLONIDINE, BUPIVACAINE, AND UNKNOWN MORPHINE. FOLLOW-UP IS BEING CONDUCTED FOR IF ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651111 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR