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

Model Number	SC-4319
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced the clik anchor shaking when the output of stimulation was increased.The physician stated that he felt a pulsating movement when the clik anchor part was shaking.No impedance abnormalities have occurred.The patient later experienced increased pain at the clik anchor site.The physician considered the pain due to the fat layer at the site being thin.An x-ray was taken and the migration of the lead and clik anchor were not confirmed.The patient underwent a revision procedure to reposition the clik anchor a little deeper, so that it is not protruding from the surface of the body.The patient is doing well postoperatively and there is no pain in the anchor area.Stimulation adjustment was performed and paresthesia was induced in the pain area.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced the clik anchor shaking when the output of stimulation was increased.The physician stated that he felt a pulsating movement when the clik anchor part was shaking.No impedance abnormalities have occurred.The patient later experienced increased pain at the clik anchor site.The physician considered the pain due to the fat layer at the site being thin.An x-ray was taken and the migration of the lead and clik anchor were not confirmed.The patient underwent a revision procedure to reposition the clik anchor a little deeper, so that it is not protruding from the surface of the body.The implantable pulse generator (ipg) and lead remain implanted.The patient is doing well postoperatively and there is no pain in the anchor area.Stimulation adjustment was performed and paresthesia was induced in the pain area.

• Brand Name: CLIK X MRI
• 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: 21107944
• Report Number: 3006630150-2024-09351
• Device Sequence Number: 8153792
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: 08714729905325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 09/02/2022
• Device Model Number: SC-4319
• Device Catalogue Number: SC-4319
• Device Lot Number: 25906262
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 09/02/2020
• 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 Sex: Unknown