BIO-MEDICUS LIFE SUPPORT TM

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 THE CONNECTOR OF THE BIO-MEDICUS LIFE SUPPORT CANNULA DID NOT CLOSE PROPERLY AND THE SHAPE OF THE CONNECTOR WAS UNUSUAL. THE CONNECTOR WAS REPLACED, AFTER WHICH IT FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS LOCATED IN THE RIGHT FEMORAL VEIN. THE DEFECT WAS NOTICED WHEN CONNECTING TO ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). WITH EASY ATTACHMENT OF THE HOSE SYSTEM, THEY OBSERVED A WATER JET COMING OUT OF THE HARD PLASTIC WHEN THE HOSE SYSTEM WAS COMPRESSED. 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.