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	Pain (1994); Discomfort (2330)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced discomfort and pain at the anchor site, the patient underwent a procedure in where the entire system was explanted.Electrocautery was used.The patient is recovered post operatively.The explanted devices will not be return as they were retained per facility policy.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, (b)(6).Product family: scs-linear leads-mri, upn: m365sc2408560, model: sc-2408-56, (b)(6).
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Product family: scs-lead fixation.Upn: m365sc2408560.Model: sc-4319.Serial: (b)(6).Batch: 32546214.Udi: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced discomfort and pain at the anchor site, the patient underwent a procedure in where the entire system was explanted.Electrocautery was used.The patient is recovered post operatively.The explanted devices will not be return as they were retained per facility policy.Additional information was received that the only devices explanted were sc-4318, lot number 34766846 and sc-4319 lot number 32546214, they were causing discomfort and pain.The patient is great post operatively.The explanted devices will not be return as they were retained per facility policy.

• 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; * 55112-5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21758595
• Report Number: 3006630150-2025-02084
• Device Sequence Number: 8766717
• Product Code: LGW
• UDI-Device Identifier: 08714729905318
• UDI-Public: (01)08714729905318(17)260905(10)34766846
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/30/2025

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: 09/05/2026
• Device Model Number: SC-4318
• Device Catalogue Number: SC-4318
• Device Lot Number: 34766846
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 09/05/2024
• 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 Age: 49 YR
• Patient Sex: Female