MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE; STYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	9735571
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used outside of a procedure.It was reported that the patient experienced a generalized convulsive seizure.It happened when the patients was already at home 8 days after the procedure.The patient presented convulsive seizures and had been hospitalized for 1 week.They received corticotherapy iv 100mg from (b)(6) 2024.The following exams had been performed: tdm on (b)(6) 2024, eeg on (b)(6) 2024, irm on (b)(6) 2024, rx on (b)(6) 2024, tdm thorax on (b)(6) 2024, tdm on (b)(6) 2024.They were released from the hospital without consequences.
Additional Manufacturer Narrative
H3, h6) no parts have been received by the manufacturer for evaluation.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VISUALASE
• Common Device Name: STYLET, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21410425
• Report Number: 1045254-2025-00513
• Device Sequence Number: 9518592
• Product Code: GAH
• UDI-Device Identifier: 00763000416461
• UDI-Public: 00763000416461
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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 Expiration Date: 07/01/2024
• Device Model Number: 9735571
• Device Catalogue Number: 9735571
• Device Lot Number: 2022070013
• 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: 02/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2022
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 70 KG