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 DURING USE OF THIS BIPOLAR MYOCARDIAL TEMPORARY PACING LEAD FOR A CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, IT WAS REPORTED THAT THE DOCTOR PUT A LAP SPONGE IN THE PATIENTS CHEST, THEN THEY STARTED TO SMELL SMOKE. THE PATIENTS CHEST WAS CHECKED, AND THE LAP SPONGE HAD CAUGHT FIRE, WHICH THEN IT WAS IMMEDIATELY REMOVED FROM THE PATIENTS CHEST. SALINE WAS APPLIED TO THE PATIENTS CHEST TO CONTROL THE FIRE. THE PATIENTS CHEST WAS EXPLORED AGAIN, AND IT WAS NOTICED THAT THE PACING WIRE WAS BURNT AND IT WAS BELIEVED THE FIRE STARTED THERE. IT WAS FURTHER NOTED THAT A SUPERFICIAL BURN WAS DISCOVERED ON THE PATIENTS HEART, AS WELL AS BURNS ON THE CHEST TUBE AND SUCTION CATHETER. A TRICUSPID VALVE REPLACEMENT, STERNAL PLATING AND LEFT ATRIAL APPENDAGE CLIP LIGATION ALSO OCCURRED CONCOMITANTLY DURING THIS PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.