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

Model Number	9734894
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Other relevant device(s) are: product id: 960-152, serial/lot #: (b)(4).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 regarding a navigation device.It was reported outside of a procedure that the images on the system were inverted.It was noted that the pixel offset settings had already been added to the overrides file.There was no patient involvement.
Additional Manufacturer Narrative
Additional information added to the event description.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Update from the manufacturer representative stated that the disc was cracked and was unable to read.They also stated that there is not another disc and that the site is currently pulling images from electronic picture archiving and communication systems (pacs).
Additional Manufacturer Narrative
The software investigation was unable to determine the probable cause of the reported issue because the behavior could not be replicated due to the disc being cracked.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8921136
• Report Number: 1723170-2019-04594
• Device Sequence Number: 19432363
• Product Code: HAW
• UDI-Device Identifier: 00643169105232
• UDI-Public: 00643169105232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/17/2019

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: 9734894
• Device Catalogue Number: 9734894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 09/30/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/12/2019; 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1