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

Model Number	SC-2318-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred three months prior to the date the manufacturer became aware of the event.Block d2b: pro code (product code): qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-2318-50.Serial number: (b)(6) batch/lot number: 5003955.Model/catalog description: infinion pro lead kit, 16 contact, 50cm unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318.Serial number: na.Batch/lot number: 36390300.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient experienced pain and felt the leads were sticking out.It was noted that patient had a non-device related weight loss and could feel where the anchor was in the back.It was also mentioned that the patient felt like the wires were bunched up.The patient underwent a procedure wherein the spinal cord stimulator (scs) leads and clik anchor were replaced.The patient was doing well postoperatively, and the explanted devices were not returned as they were discarded by the medical facility.

• Brand Name: INFINION? PRO
• 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: 24789139
• Report Number: 3006630150-2026-02071
• Device Sequence Number: 21001935
• Product Code: LGW
• UDI-Device Identifier: 00191506018726
• UDI-Public: (01)00191506018726(17)270407(10)5003927
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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 Model Number: SC-2318-50
• Device Catalogue Number: SC-2318-50
• Device Lot Number: 5003927
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 04/07/2025
• 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 Age: 59 YR
• Patient Sex: Female