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 Code	Implant Pain (4561)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: avista mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 7075821.Udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced pain at the clik anchor site of the spinal cord stimulator (scs) system while the stimulation is in use.Adjustments to the stimulation were performed, however did not alleviate the pain while the system was in use.The patient underwent a revision procedure to address the pain in which the physician opened the incision site and made the original loop around the anchor straight and the when the stimulation was turned on the patient experienced pain again.The clik anchor was repositioned 15cm away from the original location, the stimulation was turned on again, and the pain returned.The physician then repositioned the lead 10cm and then 5cm backwards from the epidural space, stimulation was turned on again, and the pain returned.The physician assessed that the stimulation irritates the epidural fat and nothing could be done to resolve the pain, he therefore decided to explant the entire system.
Event or Problem Description
It was reported that the patient experienced pain at the clik anchor site of the spinal cord stimulator (scs) system while the stimulation is in use.Adjustments to the stimulation were performed, however did not alleviate the pain while the system was in use.The patient underwent a revision procedure to address the pain in which the physician opened the incision site and made the original loop around the anchor straight, when the stimulation was turned on the patient experienced pain again.The clik anchor was repositioned 15cm away from the original location, the stimulation was turned on again, and the pain returned.The physician then repositioned the lead 10cm and then 5cm backwards from the epidural space, stimulation was turned on again, and the pain returned.The physician assessed that the stimulation irritates the epidural fat and nothing could be done to resolve the pain, he therefore decided to explant the entire system.It was additionally reported that the patient is fully recovered post operatively.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: avista mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 7075821.Udi: (b)(4).
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: avista mri, upn: m365sc2408740, model: sc-2408-74, serial: (b)(6), batch: 7075821, udi: (b)(4).The device was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers are able to confirm the root cause of the event.The device was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint and the conclusion is known inherent risk of device.
Event or Problem Description
It was reported that the patient experienced pain at the clik anchor site of the spinal cord stimulator (scs) system while the stimulation is in use.Adjustments to the stimulation were performed, however did not alleviate the pain while the system was in use.The patient underwent a revision procedure to address the pain in which the physician opened the incision site and made the original loop around the anchor straight, when the stimulation was turned on the patient experienced pain again.The clik anchor was repositioned 15cm away from the original location, the stimulation was turned on again, and the pain returned.The physician then repositioned the lead 10cm and then 5cm backwards from the epidural space, stimulation was turned on again, and the pain returned.The physician assessed that the stimulation irritates the epidural fat and nothing could be done to resolve the pain, he therefore decided to explant the entire system.It was additionally reported that the patient is fully recovered post operatively.

• 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: 21836341
• Report Number: 3006630150-2025-02460
• Device Sequence Number: 8102024
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: (01)08714729905325(17)250227(10)31084963
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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: 02/27/2025
• Device Model Number: SC-4319
• Device Catalogue Number: SC-4319
• Device Lot Number: 31084963
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 07/30/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 05/16/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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 Sex: Unknown