BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201873 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11185
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 11, 2013
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN. THE PUMP LOGS SHOWED A MOTOR STALL RECOVERY ON (B)(6) 2013 AT 14:00; THE TIME OF THE STALL WAS NOT REPORTED. THE PUMP STALLED AGAIN THE SAME DAY AT 15:57 AND RECOVERED AT 17:10. ON (B)(6) 2013, FLUOROSCOPY WAS DONE AND SHOWED THAT THE CATHETER HAD MIGRATED TO C5. ON (B)(6) 2013 THE PUMP WAS REPROGRAMMED AND THE MAXIMUM ACTIVATIONS PER/DAY WERE INCREASED. ON (B)(6) 2013, THE PUMP WAS REPROGRAMMED AND THE DAILY RATE WAS INCREASED. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MILD¿. THE PUMP WAS DELIVERING FENTANYL, BUPIVACAINE, AND CLONIDINE. IT WAS LATER REPORTED THAT ON (B)(6) 2013 THE CATHETER WAS REPOSITIONED TO C2. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302147 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention