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 Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients pain was no longer covered by the spinal cord stimulation (scs) lead.Imaging confirmed that the lead migrated.The patient underwent a revision procedure in which the lead was repositioned.No devices were implanted or explanted.The patient was doing fine postoperatively.
Additional Manufacturer Narrative
Block b3: date approximate.
Event or Problem Description
It was reported that the patients pain was no longer covered by the spinal cord stimulation (scs) lead.Imaging confirmed that the lead migrated.The patient underwent a revision procedure in which the lead was repositioned.No devices were implanted or explanted.The patient was doing fine postoperatively.
Event or Problem Description
It was reported that the patients pain was no longer covered by the spinal cord stimulation (scs) lead.Imaging confirmed that the lead migrated.The patient underwent a revision procedure in which the lead was repositioned.No devices were implanted or explanted.The patient was doing fine postoperatively.
Additional Manufacturer Narrative
Block b3: date approximate.Investigation summary: based on all available information (in the absence of product return) boston scientific has determined that lead migration is a known inherent risk with use of the device.Device history record review: a review of the manufacturing documentation for the lead revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the lead has not been returned as it remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.However, the labeling review was conducted.Labeling review: a product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief is a known risk with the use of spinal cord stimulation (scs).Investigation conclusion: the lead was not returned for analysis as it remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.Imaging from the field noted lead migration.Therefore, with the reported observations and the labeling review, it has been determined that lead migration 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 (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: 24415301
• Report Number: 3006630150-2026-01056
• Device Sequence Number: 12247004
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)251003(10)7082162
• 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
• 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,Followup
• Report Date (Section B): 05/07/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 04/15/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026; 05/07/2026
• 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