PERMANENT PACEMAKER ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE DEVICE HAD EXHIBITED INFECTION AND EROSION. A REVISION WAS PERFORMED, AND THIS IMPLANTABLE DEVICE ALONG WITH THE IMPLANTABLE LEADS WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).