MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC IGS ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733560XOMR
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device.It was reported that during a procedure the system was unresponsive.The system had to be hard shut down.System worked as intended after the reboot.Patient present with no patient impact and a two minute delay to the procedure.

• Brand Name: IGS ENT SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11619716
• Report Number: 1723170-2021-00907
• Device Sequence Number: 19653398
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• 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): 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: 4501328210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 98