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

Model Number	DB-4254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) stage 2 implant procedure, after making the usual head and chest incisions, tunneling was attempted with the boston scientific tunneling tool.After repeated attempts at shaping the tool to complete the pass, the physician attempted to modify the tip of the tunneling tool.During the subsequent tunneling attempt, the tip was found to have detached inside the patient.A small mid path incision was made to successfully remove the tunneler tip.A non boston scientific tunneling tool was then used to complete the surgery.The patient is expected to make a full recovery.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) stage 2 implant procedure, after making the usual head and chest incisions, tunneling was attempted with the boston scientific tunneling tool.After repeated attempts at shaping the tool to complete the pass, the physician attempted to modify the tip of the tunneling tool.During the subsequent tunneling attempt, the tip was found to have detached inside the patient.A small mid path incision was made to successfully remove the tunneler tip.A non boston scientific tunneling tool was then used to complete the surgery.The patient is expected to make a full recovery.

• 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: 24141884
• Report Number: 3006630150-2026-00454
• Device Sequence Number: 8841270
• Product Code: PJS
• UDI-Device Identifier: 08714729896104
• UDI-Public: (01)08714729896104(17)270514(10)36440213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/27/2026

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: 36440213
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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: 73 YR
• Patient Sex: Female