IMRIS HC300 IOHV2 HEAD FLEX COIL

Additional Manufacturer Narrative

THE BURN TO THE PATIENT'S FOREHEAD APPEARED TO HAVE BEEN CAUSED BY THE MR-CONDITIONAL MEDTRONIC AXIEM STEALTH ARRAY DEVICE THAT WAS APPLIED TO THE PATIENT'S FOREHEAD PRIOR TO AND DURING INTRAOPERATIVE SCANNING. THIS WAS THE HOSPITAL OR STAFF'S CONCLUSION. A FLEX COIL INVOLVED IN THE PROCEDURE WAS RETURNED FOR EVALUATION. IT WAS FUNCTIONALLY TESTED/ INSPECTED AND FOUND THAT THE SIGNAL TO NOISE RATIO DID NOT MEET SPECIFICATION. IT APPEARED THAT THE COIL HAD BEEN DROPPED BECAUSE THERE THE PRE-AMPS WERE FOUND TO BE LOOSE. IT WAS CONCLUDED THAT, ALTHOUGH THE COIL DID NOT MEET SNR, IT DID NOT CONTRIBUTE TO THE BURN ON THE PATIENT'S FOREHEAD.

Description of Event or Problem

A NEUROLOGICAL PROCEDURE WITH INTRAOPERATIVE SCAN TOOK PLACE ON A (B)(6) MONTH OLD PEDIATRIC PATIENT. AFTER THE MRI SCAN WAS COMPLETED AND THE PATIENT WAS UNDRAPED, A FULL-THICKNESS BURN WAS NOTED TO THE PATIENT'S FOREHEAD. PER THE HOSPITAL AND THEIR INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THE BURN WAS A MEDTRONIC MR CONDITIONAL AXIEM STEALTH ARRAY THAT WAS IN PLACE ON THE PATIENT'S FOREHEAD. THERE WERE TWO FACTORS INVOLVED IN THE BURN: FIRST, THERE WAS A DISCONNECT BETWEEN THE OR AND THE MR TECHNICIAN THAT THE DEVICE WAS IN USE AND STILL ON THE PATIENT'S FOREHEAD PRIOR TO AND DURING THE SCAN; SECONDLY, THE INSTRUCTIONS FOR USE FOR THE MEDTRONIC ARRAY WAS NOT FOLLOWED FOR USE WITHIN AN MRI, THUS CREATING A FULL-THICKNESS BURN TO THE PATIENT'S FOREHEAD BY THE UNCOILED WIRE THAT CONNECTS TO THE ARRAY. AT THE TIME OF THE SCAN, IMRIS FLEX COILS WERE BEING UTILIZED HOWEVER; THERE DOES NOT APPEAR TO BE ANY RELATIONSHIP BETWEEN THE IMRIS COMPONENTS AND THE PATIENT BURN. A HOSPITAL STAFF REPORTED THE INCIDENT TO MEDTRONIC.