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

Model Number	SC-2408-56
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: clik? x mri, upn: m365sc43190, model: sc-4319, serial: na, batch: 30903868, udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced uncomfortable stimulation in a non-target area.The patient underwent a revision procedure in which the spinal cord stimulation (scs) lead was replaced.During the procedure when the physician exposed the clik anchor, the screw was loose inside the white plastic of the anchor, as if it had unscrewed itself.The physician does not know why the clik anchor was not secured.There were no patient complications, and the patient has fully recovered.The explanted lead will not be returned as it was discarded by the medical facility.
Additional Manufacturer Narrative
Correction to initial report block b5 brand name: clik? x mri upn: m365sc43190, model: sc-4319, batch: 30903868, udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced uncomfortable stimulation in a non-target area.The patient underwent a revision procedure in which the spinal cord stimulation (scs) lead and clik anchor were replaced.During the procedure when the physician exposed the clik anchor, the screw was loose inside the white plastic of the anchor, as if it had unscrewed itself.The physician does not know why the clik anchor was not secured.There were no patient complications, and the patient has fully recovered.The explanted lead will not be returned as it was discarded by the medical facility.
Event or Problem Description
It was reported that the patient experienced uncomfortable stimulation in a non-target area.The patient underwent a revision procedure in which the spinal cord stimulation (scs) lead and clik anchor were replaced.During the procedure when the physician exposed the clik anchor, the screw was loose inside the white plastic of the anchor, as if it had unscrewed itself.The physician does not know why the clik anchor was not secured.There were no patient complications, and the patient has fully recovered.The explanted lead will not be returned as it was discarded by the medical facility.
Event or Problem Description
It was reported that the patient experienced uncomfortable stimulation in a non-target area.The patient underwent a revision procedure in which the spinal cord stimulation (scs) lead and clik anchor were replaced.During the procedure when the physician exposed the clik anchor, the screw was loose inside the white plastic of the anchor, as if it had unscrewed itself.The physician does not know why the clik anchor was not secured.There were no patient complications, and the patient has fully recovered.The explanted lead will not be returned as it was discarded by the medical facility.
Additional Manufacturer Narrative
Investigation summary: based on the available information, boston scientific has determined that the event of undesired sensations, non-target stimulation area is a known inherent risk with use of the device, as documented in the instructions for use (ifu).Device history record review: a review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: sc-2408-56, serial (b)(6) the lead was discarded by the medical facility and not returned for analysis.Therefore, a physical analysis could not be performed in our laboratory.Sc-4319, lot-batch 30903868 the clik anchor was returned and visual inspection identified a tear in the silicone portion of the clik x mri anchor at the setscrew opening, and the setscrew was not returned for evaluation.The damage is consistent with excessive mechanical force applied to the anchor.Functional testing was performed using a known good setscrew and a known good mri lead, and the clik x mri anchor successfully secured the lead without any observed anomalies.The probable cause of the clik anchor damage is unintended use error caused or contributed to the event.Labeling review: a labeling review of the lead did not reveal any anomalies as it states that system failure can occur at any time due to random failure(s) of the components.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure, all of which are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.A labeling review of the clik anchor did not reveal any anomalies as it states to insert the hex wrench into the set screw port and ensure hex wrench is fully seated.Investigation conclusion: the explanted lead was discarded, and as such physical analysis has not been conducted in our laboratory.However, a labeling review was conducted which determined that the reported event of undesired sensations, non-target stimulation area is a known risk associated with the use of the device, as documented in the ifu.The allegation that the setscrew within the clik x mri anchor was loose was confirmed.Visual inspection identified a tear in the silicone portion of the anchor at the setscrew opening, and the setscrew was not returned for evaluation.The observed damage is consistent with excessive mechanical force applied to the anchor.Although the setscrew was reported to be loose during the procedure, there is no evidence of a device defect or malfunction.The physical damage observed suggests that external mechanical forces likely contributed to the condition.Additionally, labeling instructions indicate proper engagement of the setscrew is required to secure the lead.
Additional Manufacturer Narrative
Investigation summary: based on the available information, boston scientific has determined that the event of undesired sensations, non-target stimulation area is a known inherent risk with use of the device, as documented in the instructions for use (ifu).Device history record review: a review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: sc-2408-56, serial (b)(6) the lead was discarded by the medical facility and not returned for analysis.Therefore, a physical analysis could not be performed in our laboratory.Sc-4319, lot-batch 30903868 the clik anchor was returned and visual inspection revealed that the silicone section of the clik x anchor is ripped apart.It appears that excessive mechanical force was exerted onto the anchor, resulting in the damage to its silicone section.It looks like it was damaged by a surgical tool during the revision.Record review revealed no additional information related to the complaint.The probable cause of the clik anchor damage is unintended use error caused or contributed to the event.Labeling review: a product labeling review for the lead identified that the device was used per the instructions for use (ifu) product label.Additionally, system failure, can occur at any time due to random failure(s) of the components.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure, all of which are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.A product labeling review for the clik anchor did not reveal any anomalies as it states caution: do not excessively loosen the setscrew.This may cause the setscrew to dislodge.Risk review: a review of the avista mri perc lead was completed and confirmed that the event of stimulation inadequate was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: the explanted lead was discarded, and as such physical analysis has not been conducted in our laboratory.However, a labeling review was conducted which determined that the reported event of undesired sensations, non-target stimulation area is a known risk associated with the use of the device, as documented in the ifu.

• Brand Name: AVISTA? 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24415315
• Report Number: 3006630150-2026-01057
• Device Sequence Number: 5939714
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/03/2025
• Device Model Number: SC-2408-56
• Device Catalogue Number: SC-2408-56
• Device Lot Number: 7082162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/20/2026; 05/18/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/16/2026; 05/18/2026; 05/19/2026
• Date Device Manufactured: 10/04/2023
• 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