BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2489942 · Received March 16, 2011

    Report

    Report Number
    3003807210-2009-00002
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 9, 2009
    Report Date
    December 15, 2009
    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

    THE IMRIS DEVICE IS BEING EVALUATED. A FOLLOW UP REPORT WILL BE PROVIDED AT THE CONCLUSION OF THE EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6), 2009 AN MR TECHNICIAN AT THE (B)(6) HOSPITAL LOCATED IN (B)(6) REPORTED A CASE OF A LOCALIZED BURN ON A PEDIATRIC PATIENT'S NECK FOLLOWING SURGERY FOR A CHIARA DECOMPRESSION. THE SURGERY OCCURRED ON (B)(6), 2009, HOWEVER THE LESION DID NOT MANIFEST UNTIL 24 HOURS LATER. AT THE TIME OF THE REPORT TO IMRIS THE PATIENT HAD BEEN DISCHARGED. WHEN THE EVENT WAS REPORTED TO IMRIS WE WERE ADVISED THAT THE SAH COIL HAD BEEN USED FOR THREE SIMILAR SURGERIES AFTER THE INCIDENT, WITH NO REPORTS OF REOCCURRENCE, ERRORS OR PROBLEMS. IMRIS CONTINUES TO INVESTIGATE, AND HAS NOT YET CONFIRMED WHETHER OR NOT THE IMRIS SAH COIL WAS A CONTRIBUTORY FACTOR IN THIS EVENT.

    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