DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Description of Event or Problem

IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS CONTACTED BY THE HEALTH CARE PROFESSIONAL (HCP) FOR INSTRUCTIONS ON PROGRAMMING THE PACEMAKER TO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TS INSTRUCTED THE HCP ON PROGRAMMING MRI PROTECTION MODE. THE RIGHT ATRIAL (RA) AND THIS RIGHT VENTRICULAR (RV) LEADS WERE NOT MRI CONDITIONAL LEADS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).