BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRU, HEADNECKSPINE COIL 1.5T

    MDR report key: 4448177 · Received January 20, 2015

    Report

    Report Number
    1056069-2015-00003
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 20, 2015
    Manufacturer
    INVIVO CORP
    Product Code
    MOS
    PMA / PMN Number
    K123492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. RESULTS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL. IT IS CONCLUDED THAT THIS HEATING INCIDENT IS A SKIN TO SKIN HEATING INCIDENT CAUSED BY A RF CURRENT LOOP FORMATION INSIDE THE LEFT ARM PIT OF THE PATIENT. NO PADDING WAS USED BETWEEN THE ARMS AND SIDE OF THE PATIENT TO PREVENT SKIN-SKIN CONTACT. IN THIS CASE SEVERAL FACTORS WERE OBSERVED THAT CONTRIBUTED TO THE SUSTAINED INJURY: THE PATIENT WAS OBESE AND COVERED BY A COTTON SHEET, 4 SCANS ON HIGH SAR VALUE WERE CONDUCTED AND THE TOTAL DELIVERED SPECIFIC ENERGY DOSE (SED) WAS 3726 J/KG.

    Description of Event or Problem · 1

    A MALE PT WAS POSITIONED HEAD FIRST SUPINE AND SCANNED WITH THE DS NVC COIL FOR A CERVICAL SPINE EXAMINATION. THE PT EXPERIENCED A HEATING SENSATION AND AFTER THE EXAMINATION REDDENING OF THE SKIN AND 2 BLISTERS OF 3/4 INCH WERE OBSERVED IN THE PTS LEFT ARM PIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45590 FRU, HEADNECKSPINE COIL 1.5T NVC3 MOS INVIVO CORP 4535-303-60751

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other