Description of Event or Problem · 0
BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED, INFORMATION ABOUT AN EVENT THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE ISSUE REPORTED, WAS RELATED TO IMPLANTED SPINAL CORD STIMULATOR LEADS MANUFACTURED BY MEDTRONIC. A REPORT WAS RECEIVED, THAT DURING A PROCEDURE TO CONNECT MEDTRONIC LEADS TO THE BSN IMPLANTABLE PULSE GENERATOR (IPG), A BSN SALES REPRESENTATIVE NOTICED, THE MEDTRONIC LEADS WERE SHREDDED. THE PATIENT WAS RE-IMPLANTED WITH BSN LEADS AND IPG. AND THE PATIENT IS REPORTEDLY, DOING WELL. THE MEDTRONIC LEADS WERE NOT RETURNED TO BOSTON SCIENTIFIC NEUROMODULATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).