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	Visual Impairment (2138)
Date of Event	04/30/2019
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, during the second follow-up visit, the neuro ophthalmologist noted a right superior visual field deficit.Per the investigator, it was noted that this maybe a result of edema which was expected to resolve.The patient did not report noticing this visual field deficit.It did not interfere with their daily activities.The deficit was not noted on the pi's confrontational testing.No diagnostic testing or procedures were done.No medications were administered.Relatedness to the procedure was unknown.Per the investigator, the event was not related to the thermal therapy system.The event was unresolved and no further actions were planned.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that it was a right superior homonymous quadrantanopia visual field defect.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that eye events were typically due to the presence or therapy (heat) from the catheter and therefore are typically considered related to the thermal therapy system.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that per the investigator the event was related to the thermal therapy system but was not related to the procedure.It was reported that the event was unresolved at the time of study exit.

• 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: 8666706
• Report Number: 1723170-2019-02910
• Device Sequence Number: 14018373
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/07/2020

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
• Supplement Date Received by Manufacturer: 06/07/2019; 04/24/2020; 05/01/2020
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/28/2019; 05/01/2020; 05/07/2020
• 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