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	Bacterial Infection (1735); Erythema (1840); Fever (1858); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	06/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an infection at the lead extension site of the spinal cord stimulator (scs) system.It was noted that there were secretions from the site, it was red, swollen, and the patient had a fever.The lead extension was removed, the patient was prescribed antibiotics, the area was disinfected, and the patient is doing well.It was noted the infection is thought to be related to an external non-sterile device.The device will not be returned for analysis as it was disposed of.
Additional Manufacturer Narrative
D4 - device information: we completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.The device serial number is not available, as thedevice was disposed of.
Event or Problem Description
It was reported that the patient developed an infection at the lead extension site of the spinal cord stimulator (scs) system.It was noted that there were secretions from the site, it was red, swollen, and the patient had a fever.The lead extension was removed, the patient was prescribed antibiotics, the area was disinfected, and the patient is doing well.It was noted the infection is thought to be related to an external non-sterile device.The device will not be returned for analysis as it was disposed of.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-4108.Serial number: unknown.Batch/lot number: unknown.Model/catalog description: 2x8 or cable and extension.Unique identifier (udi) # unknown.D4: device information: we completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.The device serial number is not available, as the device was disposed of.

• 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 Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22683584
• Report Number: 3006630150-2025-06059
• Device Sequence Number: 12977785
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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