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 Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced a complete loss of coverage and did not feel any stimulation on the right side during a reprogramming session.The physician stated that the leads appeared to be slightly toward the left side.A x-ray was performed and confirmed the lead migration.The patient underwent a revision procedure due to administrative reasons.During the procedure, the implanted leads were surgically exposed and inspected.An attempt was made to reposition the previously implanted the lead, however, adequate stimulation coverage was not achieved.The physician attempted to advance and implant a new lead, but the attempt was unsuccessful.Two existing leads were repositioned, resulting in improved stimulation coverage.No leads were explanted during the procedure.Improved stimulation coverage was achieved following lead repositioning.The patient was doing well postoperatively and no procedural conditions were reported.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event.Second lead: product family scs-linear leads upn unknown model unknown serial-lot unknown batch unknown udi unknown clik anchor: product family upn unknown model unknown serial n/a batch unknown udi unknown.

• 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: 50216997
• Report Number: 3006630150-2026-05806
• Device Sequence Number: 17666951
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• UDI-Public: (01)08714729767749(17)270819(10)7109623
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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 Model Number: SC-2218-70
• Device Catalogue Number: SC-2218-70
• Device Lot Number: 7109623
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 176 LB