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

Model Number	DB-2202-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Confusion/ Disorientation (2553); Insufficient Information (4580)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the deep brain stimulation (dbs) implant procedure, the patient developed delirium.The physician attributed this event to a micro-destructive effect following lead placement.As the patient was already hospitalized post-implant, he remained under medical care.The delirium has since subsided.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads.Upn: m365db2202300.Model: db-2202-30.Serial: (b)(6).Batch: 7078432.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: 7078432.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that following the deep brain stimulation (dbs) implant procedure, the patient developed delirium.The physician attributed this event to a micro-destructive effect following lead placement.As the patient was already hospitalized post-implant, he remained under medical care.The delirium has since subsided.Additional information was received that the patient has not been discharged from the hospital.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: 7078432.
Event or Problem Description
It was reported that following the deep brain stimulation (dbs) implant procedure, the patient developed delirium.The physician attributed this event to a micro-destructive effect following lead placement.As the patient was already hospitalized post-implant, he remained under medical care.The delirium has since subsided.Additional information was received that the patient has not been discharged from the hospital.Additional information was received that the patient was discharged from the hospital.Psychiatric symptoms remain under ongoing observation and clinical monitoring.

• Brand Name: VERCISE? CARTESIA?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 22031322
• Report Number: 3006630150-2025-03396
• Device Sequence Number: 18230470
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: (01)08714729905271(17)240925(10)7078432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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: 09/25/2024
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7078432
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 06/09/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/09/2025; 07/03/2025
• Date Device Manufactured: 09/26/2022
• 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 Age: 59 YR
• Patient Sex: Male