BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5T MASTER/NOVA

    MDR report key: 1872657 · Received October 4, 2010

    Report

    Report Number
    3003768277-2010-00215
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. NOTE: THE INDICATED IMPORTER HAS RECEIVED FDA EXEMPTION (B)(4) TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER (803.42) AND MANUFACTURER (803.52) FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD MR EXAM. HER RIGHT HIP WAS SCANNED WITH THE SYNERGY CARDIAC COIL ACS-NT. THE PATIENT COMPLAINED THAT SHE WAS FEELING A BURNING SENSATION. THEY STOPPED THE SCAN. THE RF CABLE FROM THE COIL WAS ACROSS THE PATIENT'S LOWER ABDOMEN. THE COIL WAS SEPARATED FROM THE SKIN BY A COTTON TEE-SHIRT. THEY, THEN PLACED A FOAM WEDGE AND TOWEL BETWEEN THE PATIENT AND THE RF CABLE, AND REPEATED THE SCAN SEQUENCE. THE PATIENT NO LONGER FELT A BURNING SENSATION. IN A LATER SEQUENCE DURING THE STUDY, THE PATIENT FELT AND RECEIVED A BURN (EGG SIZED WITH SMALL BLISTERS) ON THE UPPER FRONT OF THE THIGH NEAR THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T MASTER/NOVA LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other