MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number	DB-1432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical study patient experienced confusion and disorientation eight day post-implant procedure that was moderate in severity.The deep brain stimulation patient was admitted to the hospital and administered medication.The reported event has since resolved.The physician assessed the event as having had a probable relationship to the procedure and not device or stimulation related.
Event or Problem Description
It was reported that the clinical study patient experienced confusion and disorientation eight day post-implant procedure that was moderate in severity.The deep brain stimulation patient was admitted to the hospital and administered medication.The reported event has since resolved.The physician assessed the event as having had a probable relationship to the procedure and not device or stimulation related.Additional information was received that the patient had their medication adjusted and the device reprogrammed.

• Brand Name: VERCISE GENUS
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15366769
• Report Number: 3006630150-2022-04569
• Device Sequence Number: 6277238
• Product Code: NHL
• UDI-Device Identifier: 08714729985037
• UDI-Public: 08714729985037
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/04/2022
• Device Model Number: DB-1432
• Device Catalogue Number: DB-1432
• Device Lot Number: 201008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male