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 Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was not getting good leg coverage along with back coverage.The patient underwent a lead replacement procedure and was doing well postoperatively.The explanted products were discarded per hospital policy.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: linear st lead kit 50 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi) #: (b)(4).

• 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: 50928371
• Report Number: 3006630150-2026-07174
• Device Sequence Number: 15829778
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 7157507
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 12/18/2024
• 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 Age: 73 YR
• Patient Sex: Male