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

Model Number	SC-2218-70
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2218-70.Serial number: (b)(6).Batch/lot number: 7111965.Model/catalog description: linear st lead kit 70 cm.Unique identifier (udi)#: (b)(4).Model number/catalog number: sc-1216.Serial number: (b)(6).Batch/lot number: 817502.Model/catalog description: wavewriter alpha 16 ipg kit.Unique identifier (udi)#: (b)(4).Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient needed the percutaneous leads to be replaced with a paddle lead in the hopes of getting better back coverage.The patient underwent a spinal cord stimulator (scs) replacement procedure.No further information has been obtained.

• 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: 25773170
• Report Number: 3006630150-2026-04811
• Device Sequence Number: 5737562
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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-2218-70
• Device Catalogue Number: SC-2218-70
• Device Lot Number: 7112511
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/14/2026
• 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: 77 YR
• Patient Sex: Female