STIMROUTER

Description of Event or Problem

WE WERE INFORMED ON JUNE 11, 2024 ABOUT AN EVENT REGARDING A PATIENT THAT WAS IMPLANTED WITH A BIOVENTUS STIMROUTER X 4 APPROXIMATELY SIX MONTHS AGO. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DEVICES WERE EXPLANTED AS THEY DID NOT PROVIDE RELIEF. THE PHYSICIAN IS DR. (B)(6) AND IT TOOK PLACE AT (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORTS: #MW5158043, #MW5158044, #MW5158046.