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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 A DEEP BRAIN STIMULATION PROCEDURE, A BRAIN BLEED OCCURRED INTRAOPERATIVELY. THE PATIENT EXPERIENCED COGNITIVE DEFICITS POST-OPERATION, ALTHOUGH THE EXTENT OF THESE DEFICITS IS CURRENTLY UNKNOWN. IT WAS BELIEVED THAT A BLOOD VESSEL WAS HIT DURING MICROELECTRODE RECORDINGS, WHICH CONTRIBUTED TO THE BRAIN BLEED. AFTER BURR HOLES WERE MADE AND DEVICES WERE PLACED, MICROELECTRODE RECORDINGS WERE PERFORMED, BUT NO BENEFICIAL RESULTS WERE OBSERVED, LEADING TO THE DECISION TO ABORT THE CASE. POST-OPERATIVE COMPUTED TOMOGRAPHY CONFIRMED THE BRAIN BLEED. NO SURGICAL INTERVENTION WAS PLANNED OR OCCURRED FOLLOWING THE EVENT. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

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

ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT THE CAUSE OF THE BLEED IS STILL UNKNOWN, SURGEON SPECULATES THAT IT OCCURRED DURING THE LAST MER PASS, WHICH IT WAS THE 5TH OR 6TH MER PASS ON THE HEMISPHERE. SURGEON OBSERVED BLOOD COME UP THROUGH THE CANNULA AFTER THEY TOOK THE MICROELECTRODE OUT ON THE LAST PASS. THIS OCCURRED BEFORE THE LEADS WERE PLACED. PATIENT HAS THE BURRHOLE DEVICE WITH CLIP CLOSED AND CAPPED OFF IMPLANTED. SURGEON MAY SCHEDULE ANOTHER SURGERY LATER IN THE YEAR. THE PATIENT STAYED IN THE HOSPITAL FOR A WEEK AND IT IS UNKNOWN IF SURGERY WILL BE ATTEMPTED AGAIN.