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	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a lead revision procedure due to significant lead migration requiring repositioning.The physician experienced challenges caused by scar tissue during the placement of the replacement leads; however, the leads were successfully implanted and the procedure was completed.During the same procedure, the physician elected to replace the implantable pulse generator (ipg).Patient postoperative status was not available at the time of reporting.The disposition of the explanted devices was not provided.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-1416.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: wavewriter alpha prime 16 ipg kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2408-56.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: avista mri perc lead kit 56 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4319.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: clik x mri anchor.Unique identifier (udi) #: (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50311740
• Report Number: 3006630150-2026-06040
• Device Sequence Number: 16118428
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)280218(10)7091608
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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-2408-56
• Device Catalogue Number: SC-2408-56
• Device Lot Number: 7091608
• 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: 07/21/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 02/18/2026
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female