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

Model Number	SC-3304-25
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a normal spinal cord stimulation (scs) implant procedure.It was realized following the procedure that the expiration date of the scs lead splitter was a few days prior to the implant date.There was no visible damage when the splitter was opened, and the physician felt confident regarding the sterility of the splitter.It was confirmed the expired lead splitter would remain in the patient and there would be no further course of action.Several months later, the same lead splitter was received at boston scientifics facility for an unknown reason.It was confirmed that the model and serial number of the lead splitter received at boston scientific is the same device indicated on the patients implant documentation.The boston scientific representative was unaware of any procedure in which the lead splitter was explanted.The patient is doing well and has no problems.
Event or Problem Description
It was reported that the patient underwent a normal spinal cord stimulation (scs) implant procedure.It was realized following the procedure that the expiration date of the scs lead splitter was a few days prior to the implant date.There was no visible damage when the splitter was opened, and the physician felt confident regarding the sterility of the splitter.It was confirmed the expired lead splitter would remain in the patient and there would be no further course of action.Several months later, the same lead splitter was received at boston scientifics facility for an unknown reason.It was confirmed that the model and serial number of the lead splitter received at boston scientific is the same device indicated on the patients implant documentation.The boston scientific representative was unaware of any procedure in which the lead splitter was explanted.The patient is doing well and has no problems.Additional information received confirmed that the iead splitter was not received at boston scientifics facility.The device remains implanted in the patient and in use.

• 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; 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: 24011448
• Report Number: 3006630150-2026-00191
• Device Sequence Number: 13074113
• Product Code: LGW
• UDI-Device Identifier: 08714729779964
• UDI-Public: (01)08714729779964(17)250620(10)7070163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/02/2026

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: 06/20/2025
• Device Model Number: SC-3304-25
• Device Catalogue Number: SC-3304-25
• Device Lot Number: 7070163
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 06/21/2023
• 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 Sex: Unknown