MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-4254
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced excessive bleeding during their second stage implant procedure when the physician was using the tunneling tool.The physician believed that the tunneling tool was too sharp and malleable resulting in some additional bleeding along the tunneling track.Pressure was held over the site of the bleeding for ten minutes and the procedure was completed with no further complications.The patient has fully recovered postoperatively.The tunneling tool will not be returned as it was retained by the customer.
Additional Manufacturer Narrative
The tunneling tool was not returned for analysis; therefore, a technical analysis could not be performed.However, it was confirmed the ipg met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the event.A review of the instructions for use (ifu) confirmed that intracranial hemorrhage and injury to areas next to implant such as blood vessels, nerves, chest wall and brain are known potential risks associated with use of dbs.Based on a thorough review of the reported complaint boston scientific concluded that the probable cause of the event was unable to be established.

• Brand Name: NA
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25368555
• Report Number: 3006630150-2026-03744
• Device Sequence Number: 21197938
• Product Code: NHL
• UDI-Device Identifier: 08714729896104
• UDI-Public: (01)08714729896104(17)271211(10)38078566
• 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
• 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): 06/02/2026

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: Health Professional
• Device Model Number: DB-4254
• Device Catalogue Number: DB-4254
• Device Lot Number: 38078566
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 12/11/2025
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Female