BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3012678 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03961
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    December 22, 2012
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AT A PUMP REFILL, A MOTOR STALL WAS SEEN IN THE PATIENT'S PUMP LOGS. IT WAS ALSO NOTED THAT A "TUBE SET" MESSAGE WAS SEEN TAKING PLACE TWO DAYS AFTER THE MOTOR STALL. THE PATIENT HAD NOT HEARD AN ALARM AND FELT THAT EVERYTHING WAS GOING "OKAY." IT WAS FOUND THAT THE PATIENT HAD BEEN IN THE HOSPITAL FOR AN MRI ON THE DAY OF THE MOTOR STALL. ADDITIONALLY, A PUMP STUDY HAD BEEN PERFORMED AROUND THAT TIME AS THE PATIENT HAD BEEN HAVING "DIFFICULTIES." THE DRUGS USED IN THIS SYSTEM WERE MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115507 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization