SENSIGHT

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

IT WAS REPORTED THAT DURING STAGE 1 OF A DEEP BRAIN STIMULATION PROCEDURE, THE SCREWS ON THE BURR HOLE DEVICE KIT WERE NOT ADHERING TO THE SCREWDRIVER AND WERE NOT MAKING GOOD PURCHASE IN THE BONE. ATTEMPTS TO ANGLE THE SCREWDRIVER AND SLOWLY PLACE THE SCREWS INTO THE SIDES OF THE POLES WERE UNSUCCESSFUL. THE SCREWS WERE REPLACED WITH 4MM SCREWS FROM ANOTHER MANUFACTURER COMPANY AND THE CASE WAS CONTINUED AS USUAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.