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

Model Number	DB-2203-45
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional applicable product code: mhy.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c, serial number: n/a, batch/lot number: 35207134, model/catalog description: suretek burr hole cover kit, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient's brain lead appeared deeper in the brain than at the time of implant.A postoperative computerized tomography (ct) scan confirmed that the lead had migrated 3-4 mm deeper into the brain.The patient did not exhibit any symptoms related to the device or stimulation due to the lead position.The patient subsequently underwent a revision procedure.It was initially suspected that the retaining clip might have been open; however, upon revision, the existing retaining clip was observed securing the lead as intended.The clip was released, the lead was retracted a few millimeters, and the original clip was re-secured.An additional metallic fixation device was then placed over the bhc cap and secured to the skull with screws (device type/manufacturer was not confirmed).The patient is doing well postoperatively.Devices will not be returned to boston scientific as they remain implanted in the patient.
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-conformance's, 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 failure or malfunction of any of the device components or the battery, including but not limited to lead or lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, whether or not this requires explant and/or reimplantation and lead, lead extension (including lead extension header) and neurostimulator erosion or migration are 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: mhy.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c, serial number: n/a, batch/lot number: 35207134, model/catalog description: suretek burr hole cover kit, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient's brain lead appeared deeper in the brain than at the time of implant.A postoperative computerized tomography (ct) scan confirmed that the lead had migrated 3-4 mm deeper into the brain.The patient did not exhibit any symptoms related to the device or stimulation due to the lead position.The patient subsequently underwent a revision procedure.It was initially suspected that the retaining clip might have been open; however, upon revision, the existing retaining clip was observed securing the lead as intended.The clip was released, the lead was retracted a few millimeters, and the original clip was re-secured.An additional metallic fixation device was then placed over the bhc cap and secured to the skull with screws (device type/manufacturer was not confirmed).The patient is doing well postoperatively.Devices will not be returned to boston scientific as they remain implanted in the patient.

• Brand Name: VERCISE? CARTESIA? X
• 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: 24888495
• Report Number: 3006630150-2026-02351
• Device Sequence Number: 9835017
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)271027(10)5006011
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/04/2026

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 Model Number: DB-2203-45
• Device Catalogue Number: DB-2203-45
• Device Lot Number: 5006011
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 10/27/2025
• 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: 62 YR
• Patient Sex: Male