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	Fall (1848); Hematoma (1884); Confusion/ Disorientation (2553)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned as it remains implanted in the patient.As such, physical analysis was unable to be performed.However, it was confirmed the device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that subcutaneous hemorrhage or seroma, confusion and falls are all known risks with use of dbs.Based on a thorough review of the reported complaint boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced falls and confusion due to a hematoma discovered in the subdural, left parietal temporal lobe.The physician suspects small vessels were impacted during the left brain electrode insertion during the dbs stage one implant procedure.Therefore, the patient was hospitalized and underwent a subdural hematoma evacuation procedure.The patient has since been discharged from the hospital and is expected to fully recover.

• 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: 24933585
• Report Number: 3006630150-2026-02496
• Device Sequence Number: 5194335
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)280210(10)5008855
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/20/2026

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: 5008855
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 02/10/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White