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

Model Number	NM-3138-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent deep brain stimulation (dbs) implantation developed an infection, accompanied by fluid leakage at the lead extension site shortly after the procedure.A culture was obtained, but the results remain unavailable.The patient was treated with antibiotics and subsequently underwent an explant procedure.Postoperative recovery has been favorable.The implanted devices were retained by the medical facility and will not be submitted for analysis.
Additional Manufacturer Narrative
Correction to initial report in block: h6.Additional suspect medical device component involved in the event: product family: dbs-extension upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.(b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that a patient who underwent deep brain stimulation (dbs) implantation developed an infection, accompanied by fluid leakage at the lead extension site shortly after the procedure.A culture was obtained, but the results remain unavailable.The patient was treated with antibiotics and subsequently underwent an explant procedure.Postoperative recovery has been favorable.The implanted devices were retained by the medical facility and will not be submitted for analysis.
Event or Problem Description
It was reported that a patient who underwent deep brain stimulation (dbs) implantation developed an infection, accompanied by fluid leakage at the lead extension site shortly after the procedure.A culture was obtained, but the results remain unavailable.The patient was treated with antibiotics and subsequently underwent an explant procedure.Postoperative recovery has been favorable.The implanted devices were retained by the medical facility and will not be submitted for analysis.
Additional Manufacturer Narrative
Correction to initial report in block: h11.Block d.2b; additional applicable product codes: pjs and mhy additional suspect medical device component involved in the event: product family: dbs-extension upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7136875, udi: (b)(4).The lead extensions (serial: (b)(6) and (b)(6) were not returned for analysis as they were retained by the medical facility; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaints, boston scientific has assigned an investigation conclusion code of known inherent risk.

• Brand Name: NA
• 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: 22664025
• Report Number: 3006630150-2025-05975
• Device Sequence Number: 3678223
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)270120(10)7135904
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/07/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7135904
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/24/2025; 03/13/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/16/2025; 04/07/2026
• Date Device Manufactured: 01/19/2025
• 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: Male