[351055]
The pt first completed their radiology screening scans at the 3t-1 mri scanner by the mr technician. Following that, between approximately 8:40 am to 9 am, the participant received a series of thermal stimulations for a functional mri study to measure brain activity in the same scanner. The computer-controlled delivery of the thermal stimuli by the equipment (tsa-ii, neurosensory analyzer, medoc ltd. Advanced medical systems) had been pre-programmed and had been in use without prior incidence since sept 2001. (the baseline 32 degrees c is the "off" phase, which lasts 20 seconds; the oscillation between 44 and 47 degrees is the "on" phase, which lasts 36 seconds. The on-and-off epoch repeats 6 cycles in each run. There were total of three runs: the first and third runs were the above described "painful heat" paradigm. The second run was a "non-painful heat" paradigm with the same baseline, but the oscillation is at a lower temperature). According to protocol, a mr compatible contact thermode (surface area 3 x 3 cm) was attached via velcro at the subject's left anterior thigh extensor surface area above the knee during the functional study. Two investigators performed the functional mr scan. The delivery of the thermal stimuli was visually monitored in the control room through a computer screen that graphically reports the temperature of the contact surface. At no time during the study did the computer report temperatures that exceeded the pre-programmed range or duration (highest oscillation range 43-47 degrees c). During the last few minutes of the study, the monitor did not display a thermal graphic on the screen, only "baseline return, please wait". Because this message is the usual message displayed after each epoch, it did not alarm the investigators that there could be an overheating problem. Also, the participant and the investigators can communicate through the microphone. As the two investigators monitored the pt activity throughout the test, there was no indication from the pt that anything went wrong or excessive heat was delivered. After the subject completed the study, they reported a pain visual analog scale score of 8 (0-10, 10 being most severe) for the maximal thermal pain, which is average for this study. Routine visual inspection of the test site did not show burn or blister at that time. When the study session was over, the equipment gave an error report, advising the machine should be turned off and restarted. This resulted in normal function and graphic display of the equipment, as two investigators later tested the machine (one received the thermal stimuli inside the scan room, and one monitored the graphic display in the mr control room). The investigators shared the info with the pt, about the lack of thermal graphic info towards the end of the study. It is important to note that there was no bite-bar or physical restraint used in this study. The only appliance used in head stabilization were 2 soft foam pads lining inside the head coil. It is also important to point out that, following safety precaution each pt undergoing this study was given a hand device to squeeze to indicate the need to stop the study at any time. The pt did not indicate excessive discomfort and did not request the study to stop during the study. However, after returning home, the pt noted the development of a blister at the test site. Information about second degree burn and instructions for care were provided immediately. An appointment for clinical evaluation was arranged for the next morning. Follow-up procedures: the participant was seen at the clinic for medical evaluation. A blister containing clear fluid raised over a red base (3 x 3 cm) was observed on the extensor surface of the left thigh. The diagnosis of a contact heat-induced second degree burn was made. Dressing was applied and instructions for self care were provided. Referral to the dermatology clinic was made because of concerns about a potential scar. Dermatology consult concurred with the diagnosis and no intervention was recommended. The second degree burn is expected to heal spontaneously. Pt is expected to return to usual state of health without disability. They are being followed weekly at the clinic. Observations about permanent changes of the skin are to be made. Reporter has contacted the manufacturer, medoc, and has shipped the equipment back to the company for testing and repair.
Patient Sequence No: 1, Text Type: D, B5