[342255]
The pt first completed their radiology screening scans at the 3t-1 mri scanner by the mr technician. Following that, between approximately 9:40 am to 10 am, the pt 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 preprogrammed and had been in use without prior adverse events since sept. 2001. (the baseline 32 degree c is the "off" phase, which lasts 20 seconds; the oscillation between 44 and 47 degrese 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 3x3 cm) was attached via velcro at the subject's left anterior thigh extensor surface area above the knee during the functional study. The pt was the second study subject for that morning. Earlier that morning, another pt had completed a functional study. When the 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, as two investigators tested the equipment (one received the thermal stimuli inside the scan room, and one monitored the graphic display in the mr control room). Because the equipment was tested and found to be functioning normally, the investigators proceeded with the second pt. There was no expectation that there could be an adverse event from overheat. During the study, the delivery of the thermal stimuli was monitored in the mr control room through the computer screen as usual. At no time during the study did the computer report temperatures that exceeded the pre-programmed range (highest oscillation range 43-47 degrees c) or duration. At the end of the study (during the last run last cycles), the computer displayed "baseline return, please wait" and no thermal graphic on the screen. Because this message is the usual message displayed after each epoch, it did not alarm the investigators. As the two investigators monitored the activity throughout the test, there was no indication from the pt that anything went wrong. After the study, the pt reported a pain visual analog score of 9. 5 (0-10, 10 being most severe) and complained the site was hot. It is important to note that participant undergoing this study can communicate through the microphone in the scanner, and each participant is given a hand-held device to indicate the need to stop the study at any time. The participant reported sensing excessive heat but did not communicate it to the investigators during the study. At the completion of the scan, routine visual inspection of the test site showed redness, which was not uncommon following the study (from the thermode contact pressure). The investigators and the pt discussed about the possible equipment malfunction. Although no definitive adverse event was recognized at that time, it was recognized that the thermal delivery system has failed to function normally during the study. The participant was discharged home after the study. Later that day, the first study subject from that morning noted the development of a blister at the test site. They subesequently contacted the pi by email. The pi then immediately notified the participant by telephone to inform them about the possibility of a burn/blister. Info about second degree burn and instructions for care were provided, and a clinical appointment was made for the next morning. Follow-up procedures: the participant was evaluated at the out-pt clinic in 2003. A blister containing clear fluid over a red base (3 x 3 cm) was observed and the diagnosis of a second degree burn was made. Dressing was applied and instructions for self care were provided. Referral to the dermatology clinic was made because the subject stated that they tended to scar easily and were concerned about potential scar formation. Dermatology consult concurred with the diagnosis and no further interventon was recommended. The second degree burn is expected to heal spontaneously. The subject 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