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

Model Number	SC-2318-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Localized Skin Lesion (4542)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: brand name: infinion pro lead kit, 16 contact, 70cm, model: sc-2318-70, serial: (b)(6), batch/lot: 5005414, udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced a micro-infection at the lead insertion site.The physician assessed that given the patients significant posterior scoliosis, it was noted that the midline incision at the lead insertion site may have been subjected to persistent contact with the spinous process and anchor components, potentially causing skin abrasion.The skin at the lead insertion site had worn away, leaving a small open wound.This necessitated partial debridement as an outpatient procedure.The patients midline incision along the spinous process at the lead insertion site was reopened and the wound was irrigated with povidone-iodine solution.The patient was doing well following the procedure.The device remains implanted in the patient.
Event or Problem Description
It was reported that the patient experienced a micro-infection at the lead insertion site.The physician assessed that given the patients significant posterior scoliosis, it was noted that the midline incision at the lead insertion site may have been subjected to persistent contact with the spinous process and anchor components, potentially causing skin abrasion.The skin at the lead insertion site had worn away, leaving a small open wound.This necessitated partial debridement as an outpatient procedure.The patient's midline incision along the spinous process at the lead insertion site was reopened and the wound was irrigated with povidone-iodine solution.The patient was doing well following the procedure.The device remains implanted in the patient.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: brand name: infinion pro lead kit, 16 contacts, 70cm.Model: sc-2318-70.Serial: (b)(6).Batch/lot: 5005414.Udi: (b)(4).Based on the available information (in the absence of the product return) boston scientific has determined that the micro-infection at the lead insertion site is a known inherent risk with use of the devices, as documented in the instructions for use (ifu).The leads have not been returned by the medical facility.As such, physical analysis has not been conducted in our laboratory.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process-related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specifications prior to release for use.There is no indication that the device manufacturing process contributed to the reported complaint.A review of the labeling did not reveal any anomalies.The review confirmed that skin erosion at the ipg site can occur over time.Possible surgical procedural risks include temporary pain at the implant site, infection, cerebrospinal fluid (csf) leakage, and, although rare, epidural hemorrhage, seroma, hematoma, and paralysis.All of these are known complications and recognized risks associated with implantation of a spinal cord stimulation (scs) system.The leads were not returned for analysis as they remain implanted in the patient.The device history record review did not identify any manufacturing deviations that could have contributed to the event.However, a labeling review identified that skin abrasion and infection are recognized procedural risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.

• 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: 24634518
• Report Number: 3006630150-2026-01610
• Device Sequence Number: 8697736
• Product Code: LGW
• UDI-Device Identifier: 00191506018733
• UDI-Public: (01)00191506018733(17)270911(10)5006635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/13/2026

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-2318-70
• Device Catalogue Number: SC-2318-70
• Device Lot Number: 5006635
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 09/11/2025
• 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