MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE; LASER INSTRUMENT, SURGICAL, POWERED

Model Number	002-1100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Memory Loss/Impairment (1958)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event is associated with a clinical trial (b)(4) conducted under an investigational device exemption (ide).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a thermal therapy system.It was reported that post-operatively, the patient reported intermittently forgetting thoughts while having a conversation or when being distracted from their train of thought.The patient reported that this had happened four times since the procedure.Per the pi, this was normal for epilepsy patients.The patient also had memory problems post-operatively.No diagnostic testing or procedures were done.No medications were administered.Per the investigator, the relatedness to the procedure was unknown but the event was not related to the thermal therapy system.The event outcome was unresolved with no further actions planned.

• Brand Name: VISUALASE
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8670096
• Report Number: 1723170-2019-02970
• Device Sequence Number: 16204377
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 002-1100
• Device Catalogue Number: 002-1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 22 YR
• Patient Weight: 78