QUAD KNEE FOOT COIL 1.5T

Description of Event or Problem

THIS ADVERSE EVENT OCCURRED ON AN INTERA 1.5T SYSTEM WITH A QUAD KNEE FOOT COIL (INVIVO DESIGN) AND MICROSCOPY COIL (MR BEST DESIGN). THIS MDR SCOPE COVERS THE QUAD KNEE FOOT COIL. PATIENT WAS POSITIONED SUPINE FEET FIRST FOR BOTH KNEES EXAMINATION. THE MICROSCOPY COIL WAS POSITIONED INSIDE THE QUAD KNEE FOOT COIL. FOR THE RIGHT KNEE BOTH THE QUAD KNEE FOOT COIL ((B)(4)) AND THE MICROSCOPY COIL ((B)(4)) WERE USED. NO PADDING WAS USED INSIDE THE QUAD KNEE FOOT COIL. THE BLISTER APPEARED AT THE PRESSURE POINT WHERE THE MICROSCOPY COIL WAS IN CONTACT WITH THE KNEE. AT THE END OF THE RIGHT KNEE EXAMINATION HEATING WAS EXPERIENCED, BUT AS ONLY SOME REDDENING WAS SEEN, THE RADIOLOGIST TECHNICIAN CONTINUED WITH THE LEFT KNEE EXAMINATION. FOR THE LEFT KNEE BOTH COILS WERE CONNECTED AND POSITIONED TOGETHER, BUT THE MICROSCOPY COIL WAS NOT USED. AFTER ALL SCANNING WAS COMPLETE, THE RIGHT KNEE WAS EVALUATED AND IT WAS DETECTED A 4.7 CM 2ND DEGREE BURN. NO INJURY WAS REPORTED FOR LEFT KNEE. A TOTAL OF 22 HIGH RF SCANS WERE MADE AS PART OF THE EXAMINATION. THE EXAMINATIONS TOGETHER LASTED APPROXIMATELY 1 HOUR 18 MINUTES, OF WHICH APPROXIMATELY 1 HOUR HIGH RF SCANNING WAS DONE. (APPROXIMATELY 39 MINUTES PER KNEE).

Additional Manufacturer Narrative

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