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

Model Number	DB-2202-45
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.D2b: additional pro code selection that applies to the indication of this device: nhl, pjs.The lead and hole cover were discarded by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review of the lead did not reveal any anomalies and states that the following may be potential risks associated with the use of vercise deep brain stimulation systems: loss of adequate stimulation, weakness, muscle spasms, shaking, restlessness, or problems with movement, and implanted device components (stimulator, lead, or lead extension) may move from original implanted location or wear through the skin, which may lead to the need for additional surgery.A labeling review of the burr hole did not reveal any anomalies and states that the following may be potential risks associated with the use of vercise deep brain stimulation systems: weakness, muscle spasms, shaking, restlessness, or problems with movement.Based on all available information, engineers could not determine the root cause for the complaint, therefore concluded the cause could not be established.
Event or Problem Description
It was reported that this deep brain stimulation (dbs) patient underwent the replacement of the lead and burr hole due to loss of therapeutic benefits.Despite high stimulation in the subthalamic nucleus (stn), the patient continued to experience tremor without improvement.A computed tomography (ct) scan revealed that the lead was positioned approximately 5 mm above the intended target.No previous trauma was reported.The devices were disposed by the facility and will not be returned for analysis.Postoperatively, the patient was doing well with tremor treatment.

• 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: 25740458
• Report Number: 3006630150-2026-04757
• Device Sequence Number: 10458983
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)260722(10)7124536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 07/07/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2026
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7124536
• 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: 06/08/2026
• Initial Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 07/22/2024
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female