BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3912741 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12500
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS SCHEDULED FOR AN MRI BECAUSE OF PUMP ORIENTATION. THE PUMP WAS TILTED BUT COULD STILL BE REFILLED. IT WAS NOT SURE IF THE ORIENTATION WAS 90 DEGREES TO THE Z-AXIS OR NOT. THE SYSTEM WAS BEING USED TO DELIVER BUPIVACAINE AND COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390279 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1