BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS NEURO II-SE SPLIT ARRAY HEAD (SAH) COIL

    MDR report key: 2489969 · Received March 16, 2011

    Report

    Report Number
    3003807210-2009-00003
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 9, 2009
    Report Date
    February 1, 2010
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K061916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION, IMRIS HAS CONCLUDED THAT THE IMRIS DEVICE PERFORMED ACCORDING TO SPECIFICATIONS AND THAT THE REPORTED INCIDENT IS NOT CONSISTENT WITH AN RF BURN GENERATING FROM THE IMRIS HEAD COIL. THE CAUSE OF THE BURN IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS SUBMISSION IS INTENDED TO BE A FOLLOW UP TO AN IMRIS MDR REPORT ORIGINALLY SUBMITTED (B)(4) 2009. ADDITIONAL INFORMATION IS CONTAINED IN THE SUMMARY REPORT ATTACHED, WHICH PROVIDES THE DETAILS AND THE RESULTS OF THE IMRIS INVESTIGATION INTO THE CAUSE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-SE SPLIT ARRAY HEAD (SAH) COIL MAGNETIC RESONANCE IMAGING SYSTEM COIL LNH IMRIS, INC. 107614-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Hospitalization NOT KNOWN AT THIS TIME