MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? 3-4; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-2352-50
Medical Device Problem Codes	Off-Label Use (1494); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Pain (1994); High White Blood Cell Count (4594)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-4316.Batch/lot number: 34205183.Model/catalog description: clik anchor.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: 794160.Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced arm pain at the lead incision site and reduced stimulation coverage.As a result, the patient underwent a lead repositioning procedure.Postoperatively, the patient initially achieved excellent pain coverage.Subsequently, the patient developed fever and an elevated white blood cell count due to an infection at the arm site where the procedure had been performed, and antibiotic therapy was initiated.According to the physicians assessment, the infection was related to the procedure.The patient was admitted to the hospital beyond standard postoperative care, where the entire scs system was explanted, a wound washout was performed, and cultures were obtained.The patient has since fully recovered and has been discharged.The explanted devices will not be returned for analysis, as they were discarded by the medical facility.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced arm pain at the lead incision site and reduced stimulation coverage.As a result, the patient underwent a lead repositioning procedure.Postoperatively, the patient initially achieved excellent pain coverage.Subsequently, the patient developed fever and an elevated white blood cell count due to an infection at the arm site where the procedure had been performed, and antibiotic therapy was initiated.According to the physicians assessment, the infection was related to the procedure.The patient was admitted to the hospital beyond standard postoperative care, where the entire scs system was explanted, a wound washout was performed, and cultures were obtained.The patient has since fully recovered and has been discharged.The explanted devices will not be returned for analysis, as they were discarded by the medical facility.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-4316.Batch/lot number: 34205183.Model/catalog description: clik anchor.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: 794160.Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi) #: (b)(4).The devices have not been returned as they were discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.A labeling review did not reveal any anomalies and states that 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.Persistent pain at the ipg or lead site and undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure, all of which are known risks associated with the use of spinal cord stimulation (scs).Labelling also states the lead implant location is epidural.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The devices were not returned for analysis.However, an assessment of the investigation activities determined that, although the labeling specifies that the lead implant location is epidural and the reported use may have deviated from the intended anatomical application, the physician confirmed that the infection was related to the procedural intervention.Therefore, this investigation is assigned a probable cause of adverse event related to procedure.

• 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: 24728580
• Report Number: 3006630150-2026-01908
• Device Sequence Number: 15770445
• Product Code: LGW
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/24/2026

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 Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 7083816
• Was Device Available for Evaluation?: No
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 05/08/2026; Not provided; 08/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/26/2026; 08/21/2026; 08/24/2026
• Date Device Manufactured: 03/06/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male