BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5T MASTER CV

    MDR report key: 2003757 · Received February 24, 2011

    Report

    Report Number
    3003768277-2011-00219
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K030520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULTS, CONCLUSIONS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE PT WAS SCANNED WITH THE SYNERGY SPINE COIL ON AN INTERA 1.5T SYSTEM. THE NEXT DAY THIS PT FOUND A LARGE SECOND DEGREE BURN ON THE LOWER BACK ON THE RIGHT SIDE. THE INVESTIGATION IS STILL ONGOING ON THIS EVENT AND A FINAL REPORT WILL FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T MASTER CV LNH PHILIPS HEALTHCARE 781107

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other