MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH INAV PORTABLE SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9732585
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter: the location where the reported event was not provided.Device evaluated by mfr: the emitter was returned to the manufacturer for analysis and the reported issue was confirmed.The em interface shows faults on drives four and six.The cause was an electrical failure of the emitter.Manufacture date: device manufacturing date is unavailable at this time.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 a procedure.It was reported that the axiem box was broken, did not work properly, and was slowing down the computer.It was also noted that the field generator did not emit.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: updated with the location where this issue was observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTH INAV PORTABLE SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8449367
• Report Number: 1723170-2019-01328
• Device Sequence Number: 16250644
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 9732585
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1