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	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Discomfort (2330); Numbness (2415)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced new pain in her left anterior thigh and groin, which started a few days following a recent revision surgery (see mfg 3006630150-2024-06199).The patient expressed that the pain felt like a hot wire, causing intense soreness, numbness, and burning sensation.The patient felt the pain when the stimulation was both on or off.X-ray imaging revealed that the spinal cord stimulation (scs) lead migrated.The physician would have recommended a lead revision, but due to the new pain, he suspects a potential issue with one of her lumbar discs and has recommended a magnetic resonance imaging (mri) for further evaluation.Consequently, the patient underwent a revision procedure in which the patients two peripheral leads were explanted for mri compatibility.The explanted leads will not be returned as they were discarded by the medical facility.The patient is recovering as expected.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: linear 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 7073937.

• 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: 21297733
• Report Number: 3006630150-2025-00401
• Device Sequence Number: 18473633
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: 08714729789574
• 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): 02/03/2025

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: 03/17/2023
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 7073038
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/03/2025
• Date Device Manufactured: 03/17/2021
• 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: 49 YR
• Patient Sex: Female