MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer 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 being used outside of procedure.It was reported that the system cannot load into administrator appliance.The system stopped responding when attempting to load into the screen and a hard restart was required.
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The computer was replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CART 9733856 S7 STAFF ASSEMBLED 110V
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8170772
• Report Number: 1723170-2018-06310
• Device Sequence Number: 11102358
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1