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

Model Number	DB-2203-45
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Burning Sensation (2146); Movement Disorder (4412); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a burning sensation from the lead of the deep brain stimulation (dbs) system.The patient underwent a surgery in which it was determined that the lead is fractured.The patient is pending a replacement procedure.The patient stated that multiple reprogramming sessions were completed and did not resolve the feeling of inadequate therapy, and overstimulation at times on the one side of their body.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the cause of the patient experiencing inadequate stimulation and undergoing an exploratory procedure in which the device was assessed could not be confirmed based on record review, the device was not returned as it remains implanted.A review of the manufacturing records associated with the device indicated that it was successfully processed according to requirements.The device history review, dhr, did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.The devices remain implanted and were not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states failure or malfunction of any part of the device, including but not limited to lead or lead extension breakage, hardware malfunctions, loose connections, whether or not these problems require device removal and or replacement undesirable sensations (e.G., tingling), weakness, problems with movement, and loss of adequate stimulation are a known risks with the use of deep brain stimulation.Based on all available information, engineers are not able to confirm the root cause of the event.The device was not returned, as such, physical analysis could not be conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint, and the conclusion is cause not established.
Event or Problem Description
It was reported that the patient experienced a burning sensation from the lead of the deep brain stimulation (dbs) system.The patient underwent a surgery in which it was determined that the lead is fractured.The patient is pending a replacement procedure.The patient stated that multiple reprogramming sessions were completed and did not resolve the feeling of inadequate therapy, and overstimulation at times on the one side of their body.

• 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: 24599433
• Report Number: 3006630150-2026-01499
• Device Sequence Number: 13151984
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)270318(10)5003185
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 04/27/2026

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-2203-45
• Device Catalogue Number: DB-2203-45
• Device Lot Number: 5003185
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 03/18/2025
• 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: 66 YR
• Patient Sex: Female