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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a revision procedure to reposition the leads in order to achieve coverage of a newly identified pain area.The procedure was completed without complications.Postoperatively, the patient is recovering as expected.The device system remains implanted, and no components were explanted.
Additional Manufacturer Narrative
Block b3: exact date unknown, approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: sc-2366-70.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: linear 3-6 lead 70 cm.Unique identifier (udi) #: (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25622847
• Report Number: 3006630150-2026-04393
• Device Sequence Number: 9012077
• Product Code: LGW
• UDI-Device Identifier: 08714729789567
• UDI-Public: (01)08714729789567(17)211112(10)7070431
• 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: 2020
• 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,Followup
• Report Date (Section B): 09/14/2026

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 Expiration Date: 11/12/2021
• Device Model Number: SC-2366-70
• Device Catalogue Number: SC-2366-70
• Device Lot Number: 7070431
• 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: 05/29/2026
• Supplement Date Received by Manufacturer: 07/08/2026; 08/21/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/29/2026; 09/14/2026
• Date Device Manufactured: 11/13/2019
• 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: 83 YR
• Patient Sex: Unknown