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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: nhl, pjs.
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) procedure the tunneling tool straw became completely split when removing it down through the chest incision.Ultimately, the physician made an additional incision at the lateral aspect of the neck in order to cut out and retrieve the rest of the straw from the patients neck.
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) procedure the tunneling tool straw became completely split when removing it down through the chest incision.Ultimately, the physician made an additional incision at the lateral aspect of the neck in order to cut out and retrieve the rest of the straw from the patients neck.
Additional Manufacturer Narrative
With the limited information, in the absence of the device return, the reported event of the tunneling tool straw splitting while being used was not able to be confirmed however review of imaging provided, confirmed the straw was deformed.A review of the manufacturing documentation and media review for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was disposed by the facility and not returned for analysis; therefore, a physical analysis has not been conducted in our laboratory.The device was discarded by the facility, therefore engineers concluded and determined the probable cause was unable to exclude device problem.Block d2b additional pro-codes nhl, pjs.

• 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: 24090268
• Report Number: 3006630150-2026-00362
• Device Sequence Number: 10312721
• Product Code: MHY
• UDI-Device Identifier: 08714729896104
• UDI-Public: (01)08714729896104(17)271120(10)37975825
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 37975825
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/20/2025
• 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: 54 YR
• Patient Sex: Female