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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a revision because patient wasnt getting relief in her new pain areas.The patient was reported to be receiving good coverage of the pain areas postoperatively and was scheduled for follow-up with the local representative.The explanted montage ipg was discarded by the facility and was not returned for analysis.
Additional Manufacturer Narrative
B3: 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-2218-50 serial number: (b)(6) batch/lot number: 7077518 model/catalog description: linear st lead kit 50 cm 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: 50819543
• Report Number: 3006630150-2026-06885
• Device Sequence Number: 18679968
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)220326(10)7077267
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/26/2022
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 7077267
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 03/26/2020
• 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: 79 YR
• Patient Sex: Female