MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7´; INSTRUMENT, STEREOTAXIC

Model Number	9733857
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available on the date of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the screen was black after the device was started up and couldn't be used.When the neurosurgeon prepared the surgical navigation system for extra-surgical surgery, the navigation system turned on abnormally, and then it had the black screen and couldn't be used normally.The doctors tried to restart the surgical navigation system, but the surgical navigation was repeatedly restarted and could not be used.The doctor stopped using the malfunctioning surgical navigation system, and used the surgical microscope to replace the surgical navigation system.Then continue d the surgery, and contacted the manufacturer to repair the faulty surgical navigation system.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that there was no delay to the procedure and there were no patient complications reported.

• Brand Name: STEALTHSTATION® S7´
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9353050
• Report Number: 1723170-2019-05700
• Device Sequence Number: 2237713
• Product Code: HAW
• UDI-Device Identifier: 00643169505735
• UDI-Public: 00643169505735
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 9733857
• Device Catalogue Number: 9733857
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/24/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1