MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2366-50
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation, and the spinal cord stimulation lead placed on the right side, displayed high impedances.As such, the patient underwent a procedure where the lead was removed and a new lead was implanted; however, during the procedure, the physician discovered by x-ray that the second lead on the left had migrated.The physician replaced that lead as well.The patient was doing well postoperatively.The leads were not returned as they were retained by the customer.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb additional suspect medical device component involved in the event: product family: scs-linear leads, brand name: linear 3-6, upn: m365sc2366500, model: sc-2366-50, serial: (b)(6), lot: 7076779.

• Brand Name: LINEAR 3-6
• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22058035
• Report Number: 3006630150-2025-03521
• Device Sequence Number: 12881328
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: (01)08714729789574(17)250427(10)7078495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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: 04/27/2025
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 7078495
• 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: 04/29/2025
• Initial Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 04/28/2023
• 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: 78 YR
• Patient Sex: Female