BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2922404 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00752
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 26, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 863740 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: 2010 (B)(6), PRODUCT TYPE PUMP PRODUCT ID, 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. IT PASSED ALL INFUSION AND NON-DESTRUCTIVE TESTING, AND ALSO PASSED DISPENSE TESTING AND 30 DAY VOLUME TESTING; SHOWING THAT THE PUMP WAS DISPENSING ACCURATELY. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY. THE SC CONNECTOR SHOWED DAMAGE THAT WAS NOTED TO HAVE OCCURRED AT EXPLANT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD BEEN REPLACED DUE TO VOLUME DISCREPANCIES WHERE THE ACTUAL RESIDUAL VOLUME WAS "ABOUT 10CC MORE THAN EXPECTED DURING REFILLS". THE PATIENT WAS NOTED TO HAVE NOT EXPERIENCED ANY SYMPTOMS, WAS DOING "FINE," AND WAS RECEIVING THERAPY. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID, BUPIVACAINE, AND CLONIDINE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27988 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention