BRAINLAB ELEMENTS 6.0;ELEMENTS IMAGE FUSION;ELEMENTS IMAGE FUSION ANGIO;ELEME

Description of Event or Problem

MALPOSITION OF THE LEAD RESULTING IN LEAD EDEMA WAS REPORTED. THE CAUSE IS BELIEVED TO BE DUE TO INCORRECT PLANNING OF THE SOFTWARE (BRAINLAB) OR THE FRAME SYSTEM (RM). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).