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); Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Movement Disorder (4412); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a loss of stimulation resulting in a return in dystonia symptoms and deterioration in tone control and upper limb function.X-ray imaging was performed and confirmed that the lead extensions were fractured.The patient was scheduled for a future revision to replace both lead extensions.The revision has not yet occurred.
Additional Manufacturer Narrative
Block b3 date of event: approximation based on date that the patient first noticed the issue - (b)(6) 2025.Additional suspect medical device component involved in the event: model: nm-3138-55.Serial: (b)(6).Batch: 7080574.Catalog description: 55cm 8 contact extension.Udi: (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25303136
• Report Number: 3006630150-2026-03535
• Device Sequence Number: 15782775
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)220918(10)7079840
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 09/24/2026

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: 09/18/2022
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7079840
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 08/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/07/2026; 09/24/2026
• Date Device Manufactured: 09/18/2020
• 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: 9 YR
• Patient Sex: Male