MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC EQUIPMENT RACK 9734060 I7 110V; INSTRUMENT, STEREOTAXIC

Model Number	9734060
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be fully operational.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while in a cranial resection, the navigation system displayed a "localizer not connected" message.It was reported that the camera of the navigation system was fully connected and that the leds for the camera were green.It was reported that the navigation interface unit (niu) reset button did not restore functionality.It was reported that the navigation system was rebooted which restored functionality.There was a reported delay to the procedure of approximately 20 minutes due to this issue.
Additional Manufacturer Narrative
The software analysis determined that the logs were reviewed but provided no additional insight regarding the cause of reported complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EQUIPMENT RACK 9734060 I7 110V
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9404695
• Report Number: 1723170-2019-05846
• Device Sequence Number: 1672428
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 02/14/2020

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 Expiration Date: 08/30/2012
• Device Model Number: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 92