MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? 3-4; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2352-70
Medical Device Problem Codes	Nonstandard Device (1420); Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient presented with inadequate stimulation, described as insufficient pain relief in the targeted area.Evaluation determined that lead migration had occurred, resulting in the leads overlapping each other and contributing to the loss of coverage.Reprogramming was attempted several times with limited improvement.The patient underwent a revision procedure during which the existing leads were replaced with a paddle lead.During the same procedure, the implantable pulse generator (ipg) was replaced because the newly implanted paddle required a four port ipg.The explanted products were not released by the facility and were not returned for analysis.The patient is reported to be doing well postoperatively.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in december 2025.Additional suspect medical device components involved in the event: device#: 2, model number/catalog number: sc-1416, serial number: (b)(6), batch/lot number: 227563, model/catalog description: wavewriter alpha prime 16 ipg kit, unique identifier (udi)#: (b)(4), device#: 3, model number/catalog number: sc-2352-70, serial number: (b)(6), batch/lot number: 7083121, model/catalog description: linear 3-4 lead 70 cm, unique identifier (udi)#:(b)(4), device#: 4, model number/catalog number: sc-4318, serial number: not applicable, batch/lot number: 35501093, model/catalog description: clik x anchor sterile kit, unique identifier (udi)#: (b)(4).

• Brand Name: Linear? 3-4
• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50059941
• Report Number: 3006630150-2026-05356
• Device Sequence Number: 21509131
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)261119(10)7083119
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7083119
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 11/19/2024
• 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: 61 YR
• Patient Sex: Female