MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH S7; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from a manufacturer representative (rep) regarding a navigation system being used for a cranial resection.The rep indicated that they were unable to see the microscope bracket in the tracking window.There was a green line of communication in the software.The bracket was removed and re-added, but the bracket still could not track.The microscope was in instrument port b and the rep was unsure if this microscope had worked previously, but the bracket number did match to the sw.The rep rebooted the system and the issue resolved.There was no delay in procedure and no impact to patient outcome.
Additional Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue.Analysis found that the reported event was related to an anomaly in the medtronic navigation software anomaly tracking database.A software failure was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTH S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8515500
• Report Number: 1723170-2019-01755
• Device Sequence Number: 14152817
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 79