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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-extension, model: sc-3138-35, serial: (b)(6), batch: 7088643.
Event or Problem Description
It was reported that during the implant procedure, the physician attempted to cut scar tissue that developed around the lead and lead extension of the spinal cord stimulator (scs) system to loosen it.The physician was unable to remove the lead extension and decided to cut and explant both the lead and lead extension.The devices will not be returned for analysis as they were discarded by the 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: 21670725
• Report Number: 3006630150-2025-01756
• Device Sequence Number: 8120145
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: 08714729904823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 7079085
• 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: 03/12/2025
• Initial Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 10/07/2024
• 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 Sex: Unknown