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

Model Number	9734063
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the navigation system displayed there was no valid signal for the microscope.It was noted that there were yellow dots when utilizing high magnification.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that an interface cable was damaged on the system.Following replacement by a site biomedical engineer the reported issue was resolved.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that replacement of the microscope interface cable did not restore functionality.

• Brand Name: I7 STEALTHSTATION NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8132685
• Report Number: 1723170-2018-06052
• Device Sequence Number: 16709821
• Product Code: HAW
• UDI-Device Identifier: 00613994667472
• UDI-Public: 00613994667472
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2019

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: 9734063
• Device Catalogue Number: 9734063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 12/28/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 12/27/2018; 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1