MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE, 9731965, BALL TIP, ASSY - 4.3 MM; INSTRUMENT, STEREOTAXIC

Model Number	9731965
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 probe intermittently tracks.
Additional Manufacturer Narrative
Additional information received on the initial reporter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROBE, 9731965, BALL TIP, ASSY - 4.3 MM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9286496
• Report Number: 1723170-2019-05489
• Device Sequence Number: 16610589
• Product Code: HAW
• UDI-Device Identifier: 00885074328195
• UDI-Public: 00885074328195
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: 9731965
• Device Catalogue Number: 9731965
• Device Lot Number: 120629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1