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

Model Number	NM-3138-55
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Dyskinesia (2363); Movement Disorder (4412); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances on both leads.It was noted that this was a child dystonia patient and the lead extensions were secured using a cranial plate over the extension connection body, however, after x-ray imaging was performed it was revealed that the lead extensions had moved and were broken.The patient underwent a revision procedure where the lead extensions were replaced.The high impedances were resolved, and the patient was doing well postoperatively.
Additional Manufacturer Narrative
Block h6 device code: imdrf device problem code a27 appropriate device problem term code not available was selected because no specific migration related code exists for lead extension devices.Block b3 date of event: approximated based on the date the manufacturer became aware of the event, exact event date is unknown.
Additional Manufacturer Narrative
Correction to field h11: added additional related suspect device.Additional suspect medical device components involved in the event: model: nm-3138-55, serial: (b)(6), batch: 7127548, catalog description: 55cm 8 contact extension, udi: (b)(4).The lead extensions are in transit and have yet to be received.As such, physical analysis has not yet been conducted in our laboratory.A review of the manufacturing records associated with these devices indicated that they were successfully processed according to requirements.The 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.A labelling review was performed based on the dfu and it did not reveal any anomalies as it states pain, headache or discomfort, transient or persistent, including symptoms due to neurostimulation and motor problems such as paresis, weakness, incoordination, restlessness, muscle spasms, postural and gait disorders, tremor, dystonia, or dyskinesias, and falls or injuries resulting from these problems are known risks with the use of deep brain stimulation (dbs).The lead extensions are in transit and have yet to be received.As such, physical analysis has not yet been conducted in our laboratory.However, a labeling review was conducted.This review determined that the reported event of patient experiencing dyskinesia is a known risk with the use of deep brain stimulation (dbs).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances on both leads.It was noted that this was a child dystonia patient and the lead extensions were secured using a cranial plate over the extension connection body, however, after x-ray imaging was performed it was revealed that the lead extensions had moved and were broken.The patient underwent a revision procedure where the lead extensions were replaced.The high impedances were resolved, and the patient was doing well postoperatively.Additional information was received indicating that the specific issue the patient experienced was rapid jerking movements of the right shoulder increased and pain in the left posterior thigh.The serial numbers and implant dates of the lead extensions were obtained.It was also noted that no clear fractures were visible on the lead extensions in the x-ray imaging.

• 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; 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: 24628749
• Report Number: 3006630150-2026-01588
• Device Sequence Number: 8985860
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)260417(10)7127541
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026

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 Expiration Date: 04/17/2026
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7127541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 06/09/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/24/2026; 06/09/2026
• Date Device Manufactured: 04/17/2024
• 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 Sex: Unknown