TEMPORARY PACING WIRE

Additional Manufacturer Narrative

CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS TEMPORARY PACING LEAD IN A (B)(6) PEDIATRIC PATIENT, DURING A HEMOTHORAX RE-INTERVENTION PROCEDURE, EROSION OF THE PATIENT'S CORONARY ARTERY WAS OBSERVED. THE SURGEON BELIEVED THE EROSION OCCURRED DUE TO THE TEMPORARY PACING LEAD WHICH CAUSED FRICTION DURING THE PATIENT'S HEARTBEAT. THE LEAD WAS REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.