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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Weight Changes (2607)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, approximate event date based on gfe that states it started since january.Additional suspect medical device components involved in the event: model number/catalog number: sc-4318, serial number: n/a, batch/lot number: 29280663, model/catalog description: clik x anchor sterile kit, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient is experiencing discomfort at the lead anchor site, attributed to weight loss.There is no indication of device malfunction, and stimulation remains effective.As a result, a revision procedure has was performed to reposition the lead anchors to a deeper location.During surgery, minor amount of bipolar electrocautery was used.Post operatively, the patient is recovering as expected.
Additional Manufacturer Narrative
Block b3: exact date unknown, approximate event date based on gfe that states it started since january.Additional suspect medical device components involved in the event: model number/catalog number: sc-4318.Serial number: n/a.Batch/lot number: 29280663.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient is experiencing discomfort at the lead anchor site, attributed to weight loss.There is no indication of device malfunction, and stimulation remains effective.As a result, a revision procedure has was performed to reposition the lead anchors to a deeper location.During surgery, minor amount of bipolar electrocautery was used.Post operatively, the patient is recovering as expected.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient is experiencing discomfort at the lead anchor site, attributed to weight loss.There is no indication of device malfunction, and stimulation remains effective.As a result, a revision procedure has was performed to reposition the lead anchors to a deeper location.During surgery, minor amount of bipolar electrocautery was used.Post operatively, the patient is recovering as expected.
Additional Manufacturer Narrative
Block b3: exact date unknown, approximate event date based on gfe that states it started since (b)(6).Additional suspect medical device components involved in the event: model number/catalog number: sc-4318.Serial number: n/a.Batch/lot number: 29280663.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi) #: (b)(4).The lead anchors have not been returned as they remain implanted.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.A review of the device history record (dhr) revealed that the device met specifications prior to shipping and no anomalies or deviations related to the event occurred during manufacturing.The devices were not returned for analysis.However, the patient experienced weight loss, which resulted in discomfort at the lead anchor site due to changes in tissue coverage.There was no indication of device malfunction and stimulation remained effective.Therefore, the likely root cause is an adverse event related to patient condition.

• 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 -579
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24730440
• Report Number: 3006630150-2026-01920
• Device Sequence Number: 21153959
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 07/07/2024
• Device Model Number: SC-4318
• Device Catalogue Number: SC-4318
• Device Lot Number: 29661765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 04/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 03/31/2026; 05/21/2026
• Date Device Manufactured: 07/08/2022
• 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: 54 YR
• Patient Sex: Female