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

Model Number	9734048R
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: planning station cranial 3.0.2 exam data appear blank/distorted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system event having occurred outside of procedure.It was reported that during a stereotactic dbs demo, after loading exams and while reviewing them in the select patient and planning tasks some of the slices for different exams appeared blank or distorted.This occurred for multiple exams for different patient datasets.After rebooting the system, the exams appeared correctly, and the issue was not able to be reproduced." no patient present.

• Brand Name: NA
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8610367
• Report Number: 1723170-2019-02359
• Device Sequence Number: 11310975
• Product Code: HAW
• UDI-Device Identifier: 00643169777316
• UDI-Public: 00643169777316
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 9734048R
• Device Catalogue Number: 9734048R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1