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 Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component(s) involved in the event: brand name: linear? 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Brand name: linear? 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Additional pro code: qrb.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation as one of the spinal cord stimulation (scs) leads was not as effective in helping with the patients pain.The patient also had a new pain in a different location and therefore the patient underwent a revision procedure where one of the implanted leads was removed and two new leads were implanted in order to get better coverage.The new lead was implanted close to where the explanted lead was but slightly different area so as to cover the pain area.It is unknown which one of the three implanted leads was the one that was removed.Post operatively, the patient was doing well.The explanted lead will not be returned as it was disposed by the medical facility.

• 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: 23432695
• Report Number: 3006630150-2025-09833
• Device Sequence Number: 8672522
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: (01)08714729789574(17)250116(10)7078327
• 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): 10/30/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/16/2025
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 7078327
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 01/17/2023
• 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: 38 YR
• Patient Sex: Male