BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2962836 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02686
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N111781, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A MOTOR STALL WAS REPORTED TO HAVE OCCURRED ON (B)(6) AND A TUBE SET WAS NOTED ON (B)(6). IT WAS THOUGHT THAT THE PATIENT HAD AN MRI ON (B)(6), AND THAT THE PATIENT'S PUMP WAS NOT INTERROGATED AFTER THE MRI AND REPORTED MOTOR STALL ON (B)(6). INTERROGATION OF THE PUMP REVEALED A MOTOR STALL RECOVERY AT THE TIME OF INTERROGATION ON (B)(6). THE PATIENT WAS NOTED TO BE 'FEELING FINE.' THE MEDICATIONS USED WITHIN THE SYSTEM WERE BUPIVACAINE AND DILAUDID. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64762 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR