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	Bacterial Infection (1735); Impaired Healing (2378)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an infection at the spinal cord stimulator (scs) leads site due to impaired wound healing.The physician believed that the infection was not procedure or device related.The patient underwent a procedure wherein the leads and ipg were explanted and was doing well postoperatively.The patient was placed on antibiotics and the explanted devices were discarded by the medical facility and will not be returned.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads-mri, upn: m365sc2408560, model: sc-2408-56, serial: (b)(6), batch: 7090192, udi: (b)(4).Product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 798429, udi: (b)(4).Product family: scs-lead fixation-mri, upn: m365sc43190, model: sc-4319, batch: 34856782, udi: (b)(4).
Additional Manufacturer Narrative
Investigation results: all explanted devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: the device was not returned for analysis and the complaint as reported could not be confirmed.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable cause for the complaint and the conclusion code known inherent risk of device will be used.
Event or Problem Description
It was reported that the patient had an infection at the spinal cord stimulator (scs) leads site due to impaired wound healing.The physician believed that the infection was not procedure or device related.The patient underwent a procedure wherein the leads and ipg were explanted and was doing well postoperatively.The patient was placed on antibiotics and the explanted devices were discarded by the medical facility and will not be returned.

• 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: 24440336
• Report Number: 3006630150-2026-01088
• Device Sequence Number: 21387612
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)270727(10)7089048
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-2408-56
• Device Catalogue Number: SC-2408-56
• Device Lot Number: 7089048
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 07/27/2025
• 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 Age: 75 YR
• Patient Sex: Female