MAUDE Adverse Event Report: MPRI SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977C265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a spinal cord stimulator implant procedure, a dural tear and cerebrospinal fluid leak occurred while accessing the space to place the paddle lead wire.The procedure was aborted, and no spinal cord stimulator implant was placed.The physician patched the dural tear.The issue was resolved.The manufacturer representative (rep) indicated they would send any further information as they become aware.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22289802
• Report Number: 2649622-2025-16654
• Device Sequence Number: 15683924
• Product Code: LGW
• UDI-Device Identifier: 00763000324223
• UDI-Public: 00763000324223
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/19/2025

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: Health Professional
• Device Model Number: 977C265
• Device Catalogue Number: 977C265
• 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: 06/16/2025
• Initial Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 04/16/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 101 KG