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

Model Number 9735665

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

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

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the system functioned as expected.The system then passed the system checkout and was found to be fully functional.System manufacture date is unavailable.

Event Description

Medtronic received information regarding a navigation device being used for a cervical spine procedure.It was reported that the message "transferred exam does not have registration information.Manual registration required." was displayed.The imaging system was restarted and the exam was manually pushed to the navigation system without resolution.A self test was performed and the internal network showed no problems, however the camera cart ups connection was lost.Another reboot was attempted without resolution.An alternate navigation system was utilized to complete the procedure.There was no impact to patient.There was a reported delay to procedure of 30 minutes due to this issue.

Manufacturer Narrative

Additional information: unique device identifier (udi).Manufacture date.

Manufacturer Narrative

Analysis revealed an import failure.If information is provided in the future, a supplemental report will be issued.

• 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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7890414
• MDR Text Key: 120831932
• Report Number: 1723170-2018-04829
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• 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: 53 YR
• Patient Weight: 181