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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure of the entire system due to infection.The patient suffered a vasovagal syncope at home, not related to stimulation or the device, and sustained a head injury as a result of the fall.The wound was located in the area of the lead/lead extension juncture and subsequently became infected.The symptoms the patient experienced included redness, swelling, and fluid discharge.The patient was placed on an antibiotic regimen; however, the surgeon determined that explantation of the device was necessary.The patient is recovering normally following the explant procedure.The explanted devices were disposed of by the hospital and will not be returned to boston scientific for analysis.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002764, udi: (b)(4).Product family: dbs-extension upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001273, udi: (b)(4).Product family: dbs-extension upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001298, udi: (b)(4).

• 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: 23754015
• Report Number: 3006630150-2025-11281
• Device Sequence Number: 5892358
• Product Code: PJS
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)270326(10)5003337
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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 Model Number: DB-2203-45
• Device Catalogue Number: DB-2203-45
• Device Lot Number: 5003337
• 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: 12/01/2025
• Initial Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 03/26/2025
• 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: 49 YR
• Patient Sex: Female
• Patient Race: White