MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3138-55
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Shaking/Tremors (2515); Movement Disorder (4412); Speech Disorder (4415)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: additional pro code, qrb.Additional suspect medical device components involved in the event: product family: scs-extension upn: m365sc3138550, model: sc-3138-55, serial: (b)(6), batch: 7129616, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced pain on the lower portion left parietal area above extension headers, difficulties speaking, return of their tremor and dystonia symptoms.High impedances that continuously fluctuated were noted during functional testing on several contacts.A computed tomography (ct) and x-ray image taken exposed a slightly shaded area on one lead extension.The patient underwent a procedure wherein the physician confirmed the lead extension fracture as a result removed both lead extensions.The physician assessed the fracture was likely caused from constant bending from it slipping down the occiput into the neck.Analysis of the lead extensions was not performed as they were retained by the facility.The patient did well post-operatively.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 22322025
• Report Number: 3006630150-2025-04802
• Device Sequence Number: 15690258
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: (01)08714729760566(17)260627(10)7129616
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: 06/27/2026
• Device Model Number: SC-3138-55
• Device Catalogue Number: SC-3138-55
• Device Lot Number: 7129616
• 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: 05/27/2025
• Initial Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 06/27/2024
• 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 Age: 58 YR
• Patient Sex: Female