MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE? CARTESIA?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-2202-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Emotional Changes (1831); Cognitive Changes (2551); Confusion/ Disorientation (2553); Psychosis (4593)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized due to experiencing hallucinations, confusion and psychosis a few days post implant of the leads for the deep brain stimulation (dbs) system.The physician believes that the insertion of dbs lead could have been contributory to the episode, but not necessarily causal for the episode mentioned.It was also stated that nothing of note occurred during the procedure which may have caused the episode, and the cause remains unknown, and that an mri was performed during the hospital stay.The patient has been discharged from the hospital; therapy has been turned on and is stable.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl.Additional suspect medical device component involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7148466 model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4).

• Brand Name: VERCISE? CARTESIA?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25808463
• Report Number: 3006630150-2026-04904
• Device Sequence Number: 20321707
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)280129(10)7148423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7148423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 01/29/2026
• 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; Other
• Patient Age: 59 YR
• Patient Sex: Male