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

Model Number	SC-3138-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro code: qrb.Additional suspect medical device component involved in the event: product family: scs-non-surg acc.Upn: m365sc41080.Model: sc-4108.Serial: no information.Batch: no information.
Event or Problem Description
It was reported that the patient developed an infection at the spinal cord stimulation (scs) lead extension site.It was noted that there was visible liquid at the extension site.The lead extension was removed, the patient was prescribed antibiotics, the area was disinfected, and the patient was noted to have recovered.The physician believed the infection was procedure and device related.The device will not be returned as it was disposed by the medical facility.

• Brand Name: NA
• 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
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22821852
• Report Number: 3006630150-2025-06572
• Device Sequence Number: 15796872
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: (01)08714729760566
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/15/2025

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 Model Number: SC-3138-55
• Device Catalogue Number: SC-3138-55
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• 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 Sex: Unknown