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 A PERMANENT PACEMAKER IMPLANT TO IMPROVE HEART RATE DUE TO ARRHYTHMIA, POOR CONTACT OF A MEDTRONIC TEMPORARY CARDIAC PACING LEAD RESULTED IN INEFFECTIVE CARDIAC PACING. AS THE PATIENT WAS POSTOPERATIVE FROM CARDIAC SURGERY, THE INTRINSIC HEART RATE WAS ONLY 10¿20 BEATS PER MINUTE, AND BLOOD PRESSURE WAS UNMEASURABLE, INDICATING A CRITICAL CONDITION. USE OF THE LEAD WAS IMMEDIATELY DISCONTINUED AND REPLACED WITH A NEW PACING LEAD. THE PATIENT¿S CONDITION GRADUALLY STABILIZED THEREAFTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.