MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 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); Erosion (1750)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this deep brain stimulation (dbs) patient underwent an explant procedure to remove the leads due to erosion in the scalp on both sides.The patient scalp was noted to be too thin to accommodate both leads on one side.The leads and lead extensions were removed due to infection in consequence of the erosion.Cultures were taken and confirmed the presence of staphylococcus.As a result of the infection, the patient was placed on antibiotics.The patient was reported to be doing well postoperatively.The device will not be returned by the facility for further analysis.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: model number/catalog number: db-2203-45 serial number: (b)(6) batch/lot number: 5003711 model/catalog description: rgyle lead 45cm sterile kit unique identifier (udi): (b)(4).Additional suspect medical device components involved in the event: model number/catalog number: db-3216-55 serial number: (b)(6) batch/lot number: 5002589 model/catalog description: argyle extension 55cm sterile kit unique identifier (udi): (b)(4).Additional suspect medical device components involved in the event: model number/catalog number: db-3216-55 serial number: (b)(6) batch/lot number: 5002596 model/catalog description: argyle extension 55cm sterile kit unique identifier (udi): (b)(4).

• 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: 25627528
• Report Number: 3006630150-2026-04395
• Device Sequence Number: 15726826
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)270612(10)5003633
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/03/2026

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-2203-45
• Device Catalogue Number: DB-2203-45
• Device Lot Number: 5003633
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/03/2026
• Date Device Manufactured: 06/12/2025
• 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: 77 YR
• Patient Sex: Female