MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	S7
Medical Device Problem Codes	Computer Software Problem (1112); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that after replacing the computer for the system, it began functioning as intended.The system then passed the system checkout and was found to be fully functional.Missing device manufacture date.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the system was unresponsive during planning and the issue was resolved by rebooting.The computer was replaced several months ago nonetheless the issue that the system was unresponsive occurred for several times after the replacement.In addition, the copy and overwriting of registration points during planning occurred again.After creating registration points, deviation of level was noticed.Following recreating the registration points, overwriting occurred.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.Correction: product and related fields updated to proper value.Correction: no 510(k) provided as this device is not released for distribution in the united states.
Additional Manufacturer Narrative
The computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
Additional Manufacturer Narrative
A software analysis was performed.The issue was determined to be caused by a known software anomaly that is tracked in an internal database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Common Device Name: SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7752410
• Report Number: 1723170-2018-03828
• Device Sequence Number: 13878842
• Product Code: HAW
• UDI-Device Identifier: 00643169505735
• UDI-Public: 00643169505735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SEE H10)
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/11/2019

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: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/04/2018; 12/13/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/10/2018; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1