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 APPROXIMATELY THREE DAYS POST IMPLANT OF THESE TEMPORARY PACING LEADS, THE PATIENT DEVELOPED A HEMOTHORAX. THE MEDICAL TEAM OBSERVED A LEFT HEMOTHORAX AFTER OPENING THE RIGHT VENTRICLE TO PULMONARY ARTERY, AND AFTER THE RE-INTERVENTION, EROSION OF THE INTERNAL MAMMARY ARTERY WAS OBSERVED. THE LEADS WERE REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.