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

Model Number	SC-4316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in december 2024.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2218700.Model: sc-2218-70.(b)(6).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced deterioration of their scs implant wound site where the clik anchor and a small portion of the lead has extruded through the skin becoming exposed.Therefore, the patient was referred to a wound clinic and was given antibiotic medication and a culture was taken.No dysplastic pathologies or malignancy were identified.The patient also underwent an explant procedure during which the full scs system was removed.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Additional information provided in block d4 and block h11: unique identifier (udi) device analysis was performed on both the returned clik anchor and returned lead which revealed normal device characteristics during visual inspection of each device.A labeling review was conducted which determined that lead migration and skin erosion at the implant site can occur over time and are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation, as documented in the instructions for use (ifu).Block b3: exact date unknown, event occurred in december 2024 additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2218700.Model: sc-2218-70, serial: (b)(6), batch: 7096718, udi: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced deterioration of their scs implant wound site where the clik anchor and a small portion of the lead has extruded through the skin becoming exposed.Therefore, the patient was referred to a wound clinic and was given antibiotic medication and a culture was taken.No dysplastic pathologies or malignancy were identified.The patient also underwent an explant procedure during which the full scs system was removed.The patient was doing well postoperatively.

• Brand Name: CLICK?
• 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: 21542245
• Report Number: 3006630150-2025-01304
• Device Sequence Number: 20607812
• Product Code: LGW
• UDI-Device Identifier: 08714729793267
• UDI-Public: (01)08714729793267(17)251120(10)32804041
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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 Expiration Date: 11/20/2025
• Device Model Number: SC-4316
• Device Catalogue Number: SC-4316
• Device Lot Number: 32804041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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: 50 YR
• Patient Sex: Male