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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Muscle Weakness/Atrophy (1967); Pain (1994); Seroma (2069); Discomfort (2330); Numbness (2415)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced discomfort at the implant site, described as sharp and aching pain occurring daily along with generalized weakness in the legs.The patient also reported being unable to wear a belt because it contacted the painful area.The patient continued taking pregabalin, which was reported to be helpful.Imaging confirmed that the leads had migrated causing discomfort near the anchor site.The patient underwent a lead replacement procedure.The patient was reported to be doing well postoperatively.The facility kept the explanted product.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2318-50 serial number: (b)(6) batch/lot number: 5005669 model/catalog description: infinion pro lead kit, 16 contact, 50cm unique identifier (udi) #: (b)(4) model number/catalog number: sc-2318-50 serial number: (b)(6) batch/lot number: 5005790 model/catalog description: infinion pro lead kit, 16 contact, 50cm unique identifier (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 -579
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50786561
• Report Number: 3006630150-2026-06800
• Device Sequence Number: 18543677
• Product Code: LGW
• UDI-Device Identifier: 08714729905318
• UDI-Public: (01)08714729905318(17)270509(10)36390236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Model Number: SC-4318
• Device Catalogue Number: SC-4318
• Device Lot Number: 36390236
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 05/09/2025
• 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: 88 YR
• Patient Sex: Unknown