MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC I7; INSTRUMENT, STEREOTAXIC

Model Number	9734062
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.Initial reporter unknown at the time of filing.A medtronic representative went to the site to test the equipment.Testing revealed that the power cored to niu was unplugged.Plugging the power cord resolved the issue.The system then passed the system checkout and was found to be fully functional.Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding navigation system while in a sacroiliac and thoracolumbar procedure.It was reported that in the spine software the camera was not connecting.There was no fault light on the camera and it had two green lights.Rebooting the system twice did not resolve the issue.Site proceeded with another navigation system.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No known impact on patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received stating the reported event occurred during an anterior cervical discectomy and fusion procedure and did not cause any surgical delay.

• Brand Name: I7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8695618
• Report Number: 1723170-2019-03286
• Device Sequence Number: 2275051
• Product Code: HAW
• UDI-Device Identifier: 00613994665928
• UDI-Public: 00613994665928
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/13/2019

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: 9734062
• Device Catalogue Number: 9734062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 131