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	Loss of consciousness (2418); Syncope/Fainting (4411); Respiratory Arrest (4461)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was to undergo a spinal cord stimulation (scs) lead implant procedure.The procedure began with the administration of analgesic sedation, followed by fluoroscopic imaging.During the lead placement, the patient experienced syncope and stopped breathing.Spontaneous breathing did not return; therefore, the lead and insertion needle were removed.The patient was positioned supine, intubated, and provided anesthetic treatment.Once stabilized, the procedure was concluded with proper wound closure and disinfection.The patient was released from the hospital a few days later.It was unknown if any pre-existing medical condition could be attributed to this incident.The patient was referred to a pulmonologist to check her allergy status.
Event or Problem Description
It was reported that the patient was to undergo a spinal cord stimulation (scs) lead implant procedure.The procedure began with the administration of analgesic sedation, followed by fluoroscopic imaging.During the lead placement, the patient experienced syncope and stopped breathing.Spontaneous breathing did not return; therefore, the lead and insertion needle were removed.The patient was positioned supine, intubated, and provided anesthetic treatment.Once stabilized, the procedure was concluded with proper wound closure and disinfection.The patient was released from the hospital a few days later.There was no pre-existing medical condition that could be attributed to this incident.The patient was referred to a pulmonologist to check her allergy status.The device was discarded by the medical facility.
Additional Manufacturer Narrative
Correction to the initial mdr in block b5 and h6: patient code, impact code.The lead was discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.A review of the manufacturing records indicated that the device was successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.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 risk review of the linear 3-4 lead 70 cm was completed and confirmed that the event of respiratory arrest was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk-benefit for the product.With the available information (in the absence of the product return), boston scientific concludes that respiratory arrest during the procedure is a known inherent risk, as identified in the products risk analysis.

• 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: 23688263
• Report Number: 3006630150-2025-11041
• Device Sequence Number: 21173557
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)270715(10)7085485
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/20/2026

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: Health Professional
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7085485
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 07/15/2025
• 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: Life Threatening; Required Intervention; Hospitalization; Other
• Patient Sex: Female