MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR? 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2366-70
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Foreign Body In Patient (2687)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) lead was protruding from the patients head.The patient was hospitalized and underwent a procedure in which a portion of the lead was immediately explanted.A portion of the lead remains implanted in the patient.The portion of the lead that was explanted will not be returned as it was discarded by the medical facility.The patient has not been discharged from the hospital.
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) lead was protruding from the patients head.The patient was hospitalized and underwent a procedure in which a portion of the lead was immediately explanted.A portion of the lead remains implanted in the patient.The portion of the lead that was explanted will not be returned as it was discarded by the medical facility.The patient has not been discharged from the hospital.Additional information was received that the patient was discharged from the hospital.
Additional Manufacturer Narrative
Device technical analysis: a review of the manufacturing documentation for the lead revealed that no anomalies or deviations related to the event occurred during manufacturing.Labeling review: a labeling review of the intended use of the spinal cord stimulation (scs) system was performed and states: the intended use of the system is to treat chronic pain by stimulating the spinal cord or peripheral nerves.Risk review: a review of the linear 3-6 lead 70cm was completed and confirmed that the event of extrusion 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.Investigation conclusion: the lead was not returned, as a portion of it was discarded by the medical facility and the other portion remained implanted in the patient.As such, physical analysis has not been conducted in our laboratory.A labeling review was conducted and this review confirmed that the intended use of the scs system is to treat chronic pain by stimulating the spinal cord or peripheral nerves; however, in this case, the device had been implanted for the treatment of cluster headaches/trigeminal neuralgia, which is outside the approved intended use.Therefore, based on the available information, boston scientific concludes that the event involving the lead protruding from the patients head was likely associated with an unintended use error, given that the system was used for an indication not supported by the labeling.
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) lead was protruding from the patients head.The patient was hospitalized and underwent a procedure in which a portion of the lead was immediately explanted.A portion of the lead remains implanted in the patient.The portion of the lead that was explanted will not be returned as it was discarded by the medical facility.The patient has not been discharged from the hospital.Additional information was received that the patient was discharged from the hospital.

• Brand Name: LINEAR? 3-6
• 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: 24309614
• Report Number: 3006630150-2026-00819
• Device Sequence Number: 15872924
• Product Code: LGW
• UDI-Device Identifier: 08714729789567
• UDI-Public: (01)08714729789567(17)261113(10)7077309
• 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: 2025
• 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,Followup
• Report Date (Section B): 03/26/2026

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-2366-70
• Device Catalogue Number: SC-2366-70
• Device Lot Number: 7077309
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/19/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/10/2026; 03/26/2026
• Date Device Manufactured: 11/13/2024
• 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: Unknown