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

Model Number	DB-2203-45
Medical Device Problem Codes	High impedance (1291); Use of Device Problem (1670); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine deep brain stimulation (dbs) lead placement procedure, a lead located in the left part of the brain, which had been implanted during a previous procedure, was found to present multiple low and high impedances.The doctor explored the connection between the left brain electrode and the extension wire and identified a physical issue, as the lead was positioned at a 90-degree angle at the junction where the lead plugs into the extension wire.The doctor stated that the lead must have been damaged during the initial implant.The doctor then proceeded to straighten the kinked left brain electrode; however, this had no effect on the abnormal impedance readings.As the routine procedure did not contemplate replacement of the damaged lead, the doctor decided not to replace it and instead perform the programming around those impedances.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50168157
• Report Number: 3006630150-2026-05644
• Device Sequence Number: 5305666
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)271021(10)5005971
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 5005971
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 10/21/2025
• 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: 64 YR
• Patient Sex: Male