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	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation due to impedances displayed on the spinal cord stimulation (scs) lead.Therefore, the patient underwent a lead replacement procedure and was doing well postoperatively.The device will not be returned as it was discarded by the medical facility.
Additional Manufacturer Narrative
With all available information, boston scientific concludes that the reported event of high impedances resulting in inadequate stimulation is a known inherent risk as documented in the instructions for use (ifu).This lead was not returned as it was discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, system failure can occur at any time due to random failure(s) of the components.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control and persistent pain at the ipg or lead site, and are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.A risk review of the linear 3-4 lead 70 cm hazard analysis was completed and confirmed that the event of stimulation inadequate was defined in the risk documentation.This event type has been accounted for during product risk analysis to support an acceptable risk-benefit for the product.The lead was not returned for analysis as it was discarded by the medical facility.However, a labeling review identified that high impedances resulting in inadequate stimulation is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation due to impedances displayed on the spinal cord stimulation (scs) lead.Therefore, the patient underwent a lead replacement procedure and was doing well postoperatively.The device will not be returned as it was discarded by the medical facility.

• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24554226
• Report Number: 3006630150-2026-01385
• Device Sequence Number: 12968883
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)260730(10)7082039
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• 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
• Report Date (Section B): 04/23/2026

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: 07/30/2026
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7082039
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 07/30/2024
• 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: Male