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

Model Number 9735665

Device Problem Output Problem (3005)

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

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

No products have been returned to medtronic for analysis. Codes 4114, 3221, and 4315 are applicable. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information used during a sacroiliac and thoracolumbar procedure. It was reported that the site had stated that t he system had become intermittent. The site had rebooted the system and went back into navigation. However, when going back into navigate they were unable to see trajectory 1 view but were able to see all other views. The site used another navigation system to continue with the procedure. There was an unknown delay to the procedure. There was no impact to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was provided. It was reported that the procedure was delayed by 15 minutes. The system was rebooted and this resolved the issue.

Manufacturer Narrative

The logs were reviewed, but they did not provide any information regarding the cause of  the reported complaint. If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGN CART 9735665 STEALTH S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 10007505
• MDR Text Key: 189358551
• Report Number: 1723170-2020-01319
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse