SITUATE

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING DEBRIDEMENT, THE BODY SCANNER WAS USED HAD A DETECTION BUT THE COUNTS WERE CORRECT. THE WAND WAS USED AND IT DEEMED EVERYTHING CLEAR. HOWEVER, THE REPORTER WAS NOT SATISFIED WITH THAT BECAUSE THE PATIENT HAD A PREVIOUS SURGERY IN [REDACTED]. CALLED THE FRONT AND WAS ADVISED THAT IT WOULD BE SAFE TO GET AN X-RAY. THE X-RAY WAS COMPLETED AND DID NOT SHOW ANYTHING RETAINED. AT THE END OF THE CASE WHEN THE PATIENT WAS MOVED AND CHECKED THE BODY SCANNER AGAIN IT SHOWED CLEAR WHICH STILL HAD THE REPORTER CONCERN. THAT WAS REMOVED AND TAGGED AND PLACED AT THE FRONT DESK AT THE END OF THE FOLLOWING PATIENT CASE TO WHICH THE MAT DID THE SAME THING. IF THE BIOMED CHECKS THIS MAT IT MAY APPEAR OK UNTIL THE PATIENT IS ON THE MAT WHICH WILL SHOW DETECTION AGAIN.