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

Model Number	9733157
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
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 system being used during a cranial biopsy.It was reported that a probe would not track.The instrument was added to the procedure, and would flicker on the screen, and then immediately stopped tracking.The procedure continued with navigation, but without the biopsy system.After the case, the manufacturer representative brought the instrument into the tracking volume and the probe worked when one of the top spheres were removed/covered.She covered the top right sphere, and the probe was able to be tracked.The same was done with the top left sphere, and the probe was still able to be tracked.When both spheres were uncovered, the probe was not able to be tracked.There was no patient harm and the procedure was not delayed.

• Brand Name: PROBE NAVIGUS
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10438552
• Report Number: 1723170-2020-02240
• Device Sequence Number: 19856920
• Product Code: HAW
• UDI-Device Identifier: 00613994231413
• UDI-Public: 00613994231413
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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: 9733157
• Device Catalogue Number: 9733157
• Device Lot Number: 180511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 58