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	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspects medical device component involved in the event: model number/catalog number: sc-2408-56, serial number: (b)(6), batch/lot number: 7086073, model/catalog description: avista mri perc lead kit 56 cm, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that patient was not able to get enough pain relief.The patient underwent a lead repositioning procedure and was doing well post operatively.

• 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: 24848175
• Report Number: 3006630150-2026-02250
• Device Sequence Number: 9047312
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)261204(10)7086141
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: 7086141
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/11/2026
• Date Device Manufactured: 12/04/2024
• 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: 57 YR
• Patient Sex: Female