ILLUMISITE

Additional Manufacturer Narrative

D10: CONCOMITANT PRODUCT: UNKNOWN INTERV. LUNG SOLUTIONS PRODUCT (SERIAL#: UNKNOWN). 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

IT WAS REPORTED THAT, DURING THE PROCEDURE USING THE PROCEDURE KIT, THE LOCATABLE GUIDE WAS NOT DETECTED OR RECOGNIZED AND THE PHYSICIAN WAS UNABLE TO REGISTER THE CATHETER OR ADVANCE THE CATHETER. THE SUPERDIMENSION PORTION OF THE CASE COULD NOT BE COMPLETED BUT THE CASE WAS COMPLETED BY OTHER MEANS. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A SMALL PNEUMOTHORAX, WHICH DID NOT REQUIRE A CHEST TUBE, BUT THE PATIENT WAS ADMITTED OVERNIGHT ON OXYGEN THERAPY, WHICH EXTENDED THE HOSPITALIZATION AS A RESULT.