VERCISE GENUS DEEP BRAIN STIMULATION DEVICE

Description of Event or Problem

ON 11/28/2023 A CONSUMER CONTACTED ATL-DO TO REPORT CONCERNS WITH BOSTON SCIENTIFIC DEEP BRAIN STIMULATION DEVICE. THE CONSUMER REPORTED HAVING THE DEVICE IMPLANTED INITIALLY IN (B)(6) 2022. THE CONSUMER REPORTED THAT FOR THE PAST YEAR SHE HAVE BEEN EXPERIENCING RANDOM STIMULATION / SHOCKING DURING THE ONCE-A WEEK CHARGING. THE CONSUMER REPORTED CONTACTING BOSTON SCIENTIFIC AND THEY RECOMMENDED SURGERY TO REPLACE THE DEVICE IN HER CHEST (SIMILAR TO PACEMAKER) THAT STIMULATES THE THALAMUS. THE CONSUMER REPORT THE DEVICE WAS IMPLANTED TO TREAT HER ESSENTIAL TREMOR (ET). THE CONSUMER REPORTED HAVING SURGERY IN (B)(6) 2023 TO REPLACE DEVICE IN HER CHEST AS RECOMMENDED HOWEVER IT DID NOT CORRECT THE ISSUE THE CONSUMER IS STILL EXPERIENCING RANDOM SHOCKING DURING CHARGING. THE CONSUMER REPORTED CONTACTING BOSTON SCIENTIFIC AND REPORTING HER EXPERIENCE. THE CONSUMER REPORTED BOSTON SCIENTIFIC INFORMED HER THEY HAVE SUBMITTED A SOFTWARE UPDATE TO THE FDA AND COULD TAKE UP TO 9 MONTHS FOR APPROVAL WHICH WILL CORRECT THE MALFUNCTIONING DEVICE. THE CONSUMER REPORTED SHE HAS CONTACTED THE FDA TO REPORT HER EXPERIENCE (AND SHE REPORTS SHE BELIEVES OTHER CONSUMERS ARE HAVING THE SAME EXPERIENCE) IN HOPE THAT THE FDA WILL EXPEDITE THE SOFTWARE APPROVAL IF THEY KNEW PEOPLE ARE WAITING. THE INFORMATION PROVIDED BY CONSUMER IN THIS COMPLAINT IS FOR THE OLD (REMOVED) DEVICE. THE CONSUMER REPORTED SHE HAS NOT RECEIVED THE NEW CARD FOR THE NEWLY IMPLANTED DEVICE. FIRST DEVICE IMPLANTED (B)(6) 2022, AND REPLACED (B)(6) 2023: VERCISE, MODEL DB-64125, US. MEDICAL DEVICE BOSTON SCIENTIFIC IP, MODEL#: DB-1216, SERIAL#: (B)(6), PRODUCTION: IPG, BOSTON SCIENTIFIC VERCISE GENUS DEEP BRAIN STIMULATION DEVICE (DBS): IMPLANTED DEVICE.