MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? ST; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2218-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients stimulation therapy was not adequately targeting the areas requiring pain relief.It was noted that the leads had migrated which was confirmed through imaging.Program optimization was performed, and the spinal cord stimulator (scs) device was functioning as intended.The patient underwent a procedure wherein an additional scs lead was implanted.The patient was reported to be doing well postoperatively.The devices remain implanted and in use.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2218-50.Serial number: (b)(6).Batch/lot number: 7168829.Model/catalog description: linear st lead kit 50 cm.Unique identifier (udi) #: (b)(4).Investigation results: the spinal cord stimulator (scs) leads were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: a review of the device history record (dhr) did not identify any manufacturing-related nonconformances, deviations, or anomalies that could be associated with the reported event.A review of the applicable labeling did not reveal any discrepancies as it appropriately addresses; migration, pain and stimulation inadequate.The reported imaging required and reprogramming of device are considered a secondary outcome of the reported event.The devices were not returned for analysis; therefore, a physical evaluation could not be performed.The investigation was limited to the information and documentation available at the time of review.Evaluation of the complaint record did not identify objective evidence to confirm the reported allegation or determine a cause.Based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.

• Brand Name: Linear? ST
• 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: 50858981
• Report Number: 3006630150-2026-07000
• Device Sequence Number: 13246013
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 7175771
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 12/07/2025
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 203 LB