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

Model Number	960-553
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.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 tip of the sharp planar passive probe was bent.No patient present.
Additional Manufacturer Narrative
Additional information: although it appeared on the screen, it exceeded the acceptable range when attempting to verify.The sharp planar passive probe was returned to the manufacturer for analysis.Analysis found that the returned probe was well worn and all the color has faded from the probe.The tip was slightly bent, but with markers attached and fully seated the probe returned good geometry and divot error readings.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8210156
• Report Number: 1723170-2019-00033
• Device Sequence Number: 334585
• Product Code: HAW
• UDI-Device Identifier: 00673978090108
• UDI-Public: 00673978090108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 960-553
• Device Catalogue Number: 960-553
• Device Lot Number: 3120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1