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

Model Number	SC-4318
Medical Device Problem Codes	Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Discomfort (2330); Shaking/Tremors (2515); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had swelling and redness at the anchor site due the possibility that the patient's body was rejecting the anchor.It was noted that the patient's click anchors were palpable causing pain and discomfort at the midline incision site preventing the patient to lay flat on the back or sit straight.Multiple reprogramming were made but caused the patient legs to frazzle.The patient underwent an explant procedure and the explanted devices will not be returned as they were retained by the facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-ipg-pc, upn: m365sc14160, model: sc-1416, serial: (b)(6); product family: sc-2352-50, upn: m365sc2352500, model: sc-2352-50, serial: (b)(6).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced swelling at the anchor site with midline discomfort and radiating flank pain.Fluoroscopic imaging confirmed that the leads had not migrated.Reprogramming efforts were unsuccessful, and the patient subsequently reported jittery sensations in her legs.The patient later underwent an explant procedure during which the entire scs system was removed.The devices were not returned for analysis, as they were retained by the facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-1416.Serial: (b)(6).Batch: 228905.Model/catalog description: wavewriter alpha prime 16 ipg kit.Unique identifier: (b)(4).Model: sc-2352-50.Serial: (b)(6).Batch: 7081087.Model/catalog description: linear 3-4 lead 50 cm.Unique identifier: (b)(4).Model: sc-2352-50.Serial: (b)(6).Batch: 7081490.Model/catalog description: linear 3-4 lead 50 cm.Unique identifier: (b)(4).

• Brand Name: CLIK? X
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21586257
• Report Number: 3006630150-2025-01449
• Device Sequence Number: 8896409
• Product Code: LGW
• UDI-Device Identifier: 08714729905318
• UDI-Public: (01)08714729905318(17)260425(10)33872615
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/25/2026
• Device Model Number: SC-4318
• Device Catalogue Number: SC-4318
• Device Lot Number: 33872615
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 04/25/2024
• 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: Female
• Patient Weight: 57 KG