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

Model Number	SC-2408-74
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate therapy.Imaging identified that the lead migrated from the t10 to the t12 vertebrae and was no longer able to deliver appropriate therapy.Therefore, the patient underwent a lead replacement procedure.The patient was doing well postoperatively.The lead will not be returned as it was discarded by the medical facility.The device serial number and original implant date are unknown and cannot be obtained despite good faith effort.
Event or Problem Description
It was reported that the patient experienced inadequate therapy.Imaging identified that the lead migrated from the t10 to the t12 vertebrae and was no longer able to deliver appropriate therapy.Therefore, the patient underwent a lead replacement procedure.The patient was doing well postoperatively.The lead will not be returned as it was discarded by the medical facility.The device serial number and original implant date are unknown and cannot be obtained despite good faith effort.
Additional Manufacturer Narrative
The lead was discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.However, the labeling review was conducted.A product labeling review identified that the device was used per the instructions for use (ifu) product label.The ifu states that lead migration may occur over time.Lead migration can result in undesirable changes in stimulation and a reduction in pain relief.Undesirable stimulation may also occur over time due to cellular changes in the tissue surrounding the electrodes, changes in electrode position, loose electrical connections, or lead failure.Additionally, persistent pain at the ipg or lead site is also a known risk of implanting a pulse generator as part of a spinal cord stimulation system.A review of the manufacturing documentation for this device was unable to be performed as the device information is unknown despite good faith effort to obtain.A risk review was completed and confirmed that the event of lead migration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support an acceptable risk-benefit for the product.The lead was not returned for analysis as it was discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.Imaging from the field identified lead migration.Therefore, with the reported observations and the labeling review, it has been determined that inadequate stimulation was likely a result of lead migration and is a known inherent risk with use of the devices, 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 Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24089458
• Report Number: 3006630150-2026-00358
• Device Sequence Number: 5827838
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: (01)08714729904823
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 03/24/2026

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 Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown