STREAMLINE TEMPORARY PACING LEADS

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

MEDTRONIC RECEIVED INFORMATION THAT 24 HOURS OR 1 DAY POST IMPLANT OF THIS TEMPORARY MYOCARDIAL PACING WIRE, IT WAS REPORTED THAT THE WIRE WAS NOT WORKING. IT WAS FURTHER NOTED THAT THE PACING WIRE HAD NOT DELIVERED PACING OR PROVIDED CAPTURE, EVEN ON THE MAXIMUM SETTING. IT WAS FURTHER NOTED THAT THE SURGEON HAD USED AN EXTRA SUTURE TIED AROUND THE PACING WIRE IN ORDER TO HELP SECURE THE PACING WIRE TO THE EPICARDIUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.