MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Event date is approximated.A manufacturer representative went to the site to test the equipment.It was identified there was a black screen on the main cart monitor.The camera cart monitor was working properly.Both monitors were switched.The black screen monitor was mounted from the main cart plug with hdmi to the camera cart using "dp in" connection.The "good screen" was mounted on the main cart showing no video signal.The menu was used to select "dp in to hdmi" and there was a signal.When the black monitor was present, the system was restarted but the no signal remained.The menu screen was used to select from "hdmi to dp in" and the issue was resolved.The navigation system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used for a spinal fusion procedure.It was reported that during surgery, after having the navigation system be on for more than 2 hours, the main cart suddenly turned green and then completely black.The led mon the monitor was also off.There was no patient impact as the surgery had been done using the camera cart monitor.There was less than an hour delay due to the reported issue.

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7538993
• MDR Text Key: 109100083
• Report Number: 1723170-2018-02241
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 50