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

Model Number	DB-4254
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during deep brain stimulation (dbs) stage 2, the straw from the tunneling tool became caught in tissue during the tunneling process and led to bleeding.Due to deformation and loss of function of the outer sheath, the tunneling process could not be completed with the initial product.During the event, the sheath catching within the tissue was associated with increased resistance and resulted in notable bleeding at the tunneling site.Hemostasis was achieved intraoperatively.The tunneling device was replaced with a new unit, which functioned as intended and allowed successful completion of the procedure.The patient tolerated the remainder of the procedure well and is expected to recover without complications.The device was discarded at the facility and will not be returned to boston scientific for analysis.
Additional Manufacturer Narrative
Block d2b: additional applicable product code: nhl.The device was discarded at the facility and not returned for analysis; therefore, a technical analysis could not be performed.Media inspection confirmed the damage of the straw from the tunneling tool.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, 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 the following may be potential risks associated with its use: injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the brain and intracranial hemorrhage (which can lead to stroke, paralysis, or death).Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not 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: 25167327
• Report Number: 3006630150-2026-03135
• Device Sequence Number: 15998011
• Product Code: MHY
• UDI-Device Identifier: 08714729896104
• UDI-Public: (01)08714729896104(17)270915(10)37397914
• 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
• 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): 05/13/2026

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-4254
• Device Catalogue Number: DB-4254
• Device Lot Number: 37397914
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 09/15/2025
• 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: 85 YR
• Patient Sex: Male