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	Bacterial Infection (1735); Erythema (1840); Fever (1858); Inflammation (1932)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed a staph infection that started in the battery site and traveled into the midline incision and into anchors.Symptoms of fever, redness and inflammation.A stitch pooped through the skin was the cause on the infection.The patient was placed on antibiotics.The patient underwent a spinal cord stimulation (scs) explant procedure.The patient was doing well postoperatively.The explanted device components were discarded by the facility.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-ipg-r-mri, upn: m365sc12160, model: sc-1216, serial: (b)(6), batch: 779784, udi: (b)(4).Product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: 7156421/7158117, udi: (b)(4), udi: (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: 21973375
• Report Number: 3006630150-2025-03130
• Device Sequence Number: 9170794
• Product Code: LGW
• UDI-Device Identifier: 08714729905318
• UDI-Public: (01)08714729905318(17)261113(10)35211201
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 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
• Report Date (Section B): 05/06/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-4318
• Device Catalogue Number: SC-4318
• Device Lot Number: 35211201
• 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: 04/11/2025
• Initial Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 11/13/2024
• 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: 58 YR
• Patient Sex: Male