BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 88780 · Received April 27, 1997

    Report

    Report Number
    88780
    Event Type
    Injury
    Date Received
    April 27, 1997
    Date of Event
    April 4, 1997
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A 2 TO 3 HOUR MRI SET OF PROCEDURES (LUMBER SPINE SCANS), A VERY LARGE WOMAN (WEIGHT WAS ESTIMATED BETWEEN 200 AND 230 LBS.) UNDER ANESTHESIA RECEIVED SEVERAL SKIN BURNS BENEATH THE ECG ELECTRODES. TWO SETS OF 3 BURNS (EARLY INDICATIONS BELIEVED BURNS WERE FIRST AND SECOND DEGREE BURNS) WERE REPORTED. APPARENTLY, DURING THE MRI SCANS, THE OPERATORS OBSERVED SKIN HEATING BENEATH THE ECG ELECTRODES, AND REPLACED AND REPOSITIONED THE ECG ELECTRODES, AND A SECOND SET OF BURNS OCCURRED BENEATH THE SECOND SET OF ELECTRODES. THE HEATING AT THE SKIN WAS SEVERE ENOUGH THAT THE PLASTIC CLIPS OF THE ECG LEAD WIRES BECAME PARTIALLY MELTED. THE SCANS PERFORMED OCCURRED OVER A 2 TO 3 HOUR PERIOD, DURING WHICH THE PATIENT WAS DIAPHORETIC (I.E. SWEATING). THE PATIENT WAS RESTRAINED WITHIN THE MRI BORE SEVERAL TIMES DURING THE PROLONGED SCAN PERIOD. THE PATIENT'S SKIN BURNS WERE TREATED IN THE EMERGENCY ROOM WITH SILVADENE CREAM, AND THE PATIENT WAS THEN RETURNED TO THE MRI FOR FURTHER SCANNING (THORACIC AND CERVICAL SPINE SCANS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ECG LEADS DRT INVIVO RESEARCH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Congenital Anomaly MEDLINE 9| GENERAL ELECTRIC 1.5 TESLA MRI SYSTEM,