BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4152899 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18505
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 18, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS USED TO DELIVER BUPIVACAINE AND MORPHINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WANTED TO REPLACE THE PUMP AND CATHETER DUE TO A VOLUME DISCREPANCY OF 3ML AT THE LAST REFILL ((B)(6) 2014; EXPECTED RESERVOIR VOLUME (ERV) 0ML, ACTUAL RESERVOIR VOLUME (ARV) 3ML). IT WAS REPORTEDLY UNCLEAR WHY 0ML WAS EXPECTED OR IF THE PATIENT MISSED A ¿REFILL OR SOMETHING.¿ IT WAS ALSO UNKNOWN IF THE PUMP WAS ALARMING. THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF; ONSET AND DURATION WAS UNKNOWN. THE PATIENT HAD A REFILL SCHEDULED FOR THE FOLLOWING WEEK. THERE WAS ALSO NOTED A 6ML VOLUME DISCREPANCY IN THE PAST, BUT THE DETAILS WERE UNKNOWN. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND MORPHINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. 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
    630429 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention