MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number	960-539
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned 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 for an electrode and probe placement.It was reported that the after the surgeon had tightened the screw the guidance tool moved.Even if tightened really hard.There was no reported delay and no report impact to patient outcome.The site switched to a different guide tool to proceed with the procedure.

• Brand Name: SURGN CART 9735665 STEALTH S8 PREMIUM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10097255
• Report Number: 1723170-2020-01540
• Device Sequence Number: 3387325
• Product Code: HAW
• UDI-Device Identifier: 00681490991520
• UDI-Public: 00681490991520
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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 Expiration Date: 02/28/2014
• Device Model Number: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 080202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1