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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840)
Date of Event	11/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event likely occurred prior to (b)(6) 2025.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient developed redness at the sacrum and a minor infection at the lead entry point.As a result, the patient underwent a lead explant and was placed on antibiotics.According to the physician, the infection was not related to the device or the procedure.Postoperatively, the patient is doing well.The lead will not be returned for analysis as it was discarded by the medical facility.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient developed redness at the sacrum and a minor infection at the lead entry point.As a result, the patient underwent a lead explant and was placed on antibiotics.According to the physician, the infection was not related to the device or the procedure.Postoperatively, the patient is doing well.The lead will not be returned for analysis as it was discarded by the medical facility.
Additional Manufacturer Narrative
Block b3: exact date unknown, event likely occurred prior to 01dec2025.The lead has not been returned as it was discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.A product labeling review was conducted and revealed no anomalies.Additionally, tissue reaction to implanted materials can occur and possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (csf) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis, all of which are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was not returned for analysis.However, a labelling review found that the reported event is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation (scs).

• 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: 23873374
• Report Number: 3006630150-2025-11606
• Device Sequence Number: 19988434
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)270318(10)7083937
• 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: 2025
• Device Explanted Year: 2025
• 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): 04/15/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7083937
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 03/18/2025
• 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: 88 YR
• Patient Sex: Female