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	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads-mri.Brand name: avista? mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Lot: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that one of two spinal cord stimulation (scs) leads displayed high impedances, and the patients pain area was spreading.Therefore, the patient underwent a procedure where two leads were replaced.There were no adverse events reported postoperatively.The devices were discarded by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads-mri.Brand name: avista? mri.Upn: m365sc240874.Model: sc-2408-74.Serial: (b)(6).Lot: (b)(6).Udi: (b)(4).Based on limited information, in the absence of the device return, the reported event of high impedances resulting in inadequate stimulation and associated pain spreading is unable to be established.A review of the manufacturing documentation for the leads revealed that no anomalies or deviations related to the event occurred during manufacturing.The leads were not returned for analysis; therefore, a physical analysis has not been conducted in our laboratory.A product labeling review identified that the devices were 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.The explanted leads were discarded by the medical facility, and a technical product analysis could not be carried out.Therefore, with the available information, the root cause of the reported clinical observations was unable to be determined.
Event or Problem Description
It was reported that one of two spinal cord stimulation (scs) leads displayed high impedances, and the patients pain area was spreading.Therefore, the patient underwent a procedure where two leads were replaced.There were no adverse events reported postoperatively.The devices were discarded by the medical facility.

• 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: 23411509
• Report Number: 3006630150-2025-09677
• Device Sequence Number: 9085021
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: (01)08714729904823(17)260619(10)7078727
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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): 05/28/2026

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: 06/19/2026
• Device Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 7078727
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 06/19/2024
• 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: 74 YR
• Patient Sex: Female