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	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients spinal cord stimulator lead had migrated due to patient had a fall.Unknown if the fall was device related.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2408-56 serial number: (b)(6) batch/lot number: 7085478 model/catalog description: avista mri perc lead kit 56 cm 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 0646- 2602; PR 0646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50809448
• Report Number: 3006630150-2026-06864
• Device Sequence Number: 15602653
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: (01)08714729904816(17)260917(10)7085464
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Expiration Date: 09/17/2026
• Device Model Number: SC-2408-56
• Device Catalogue Number: SC-2408-56
• Device Lot Number: 7085464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 09/17/2024
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Female