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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices remain implanted in the patient; 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 did not reveal any anomalies and states that subcutaneous hemorrhage or seroma (blood or fluid collection under the skin, including the skin over the skull), is a known risk with the use of deep brain stimulation.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.Block d2b: additional applicable product code: nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7147445 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a stage 1 dbs implant procedure in which the machine for electrophysiological recording (mer) caused a bleed in the basal ganglia (bg), specifically in the external segment of the globus pallidus (gpe).Suction was performed to remove the blood from the canula and stop the bleeding.The patient did not exhibit any symptoms.Postoperatively, computed tomography (ct) showed no evidence of brain bleed.The patient was discharged from the hospital, and it was confirmed that they were not admitted beyond the standard of care.The patient is expected to fully recover.The device will not be returned to boston scientific as it remains implanted in the patient.

• 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: 25062021
• Report Number: 3006630150-2026-02829
• Device Sequence Number: 9354378
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)280112(10)7147860
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: 7147860
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 01/12/2026
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female