MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4), udi#: (b)(4). Software analysis determined that the reported behavior was consistent with a known software anomaly. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for an spinal procedure. After completing an image acquisition, the scan did not automatically transfer to the navigation system. When attempting to manually push the scan over to the navigation system, the site was unable to register with it. The site had to do a manual registration. Technical services advised to see if the scan had a nav tag. If there was no nav tag, the site would need to retake the image acquisition or do manual registration. It was determined that the image did not have a nav tag. The site decided to retake the image acquisition. The issue was considered resolved. The reported issue resulted in a procedure delay of less than one hour. The impact to the patient was not provided.

Event Description

Medtronic received information regarding a navigation system being used for an spinal procedure. After completing an image acquisition, the scan did not automatically transfer to the navigation system. When attempting to manually push the scan over to the navigation system, the site was unable to register with it. The site had to do a manual registration. Technical services advised to see if the scan had a nav tag. If there was no nav tag, the site would need to retake the image acquisition or do manual registration. It was determined that the image did not have a nav tag. The site decided to retake the image acquisition. The issue was considered resolved. The reported issue resulted in a procedure delay of less than one hour. The impact to the patient was not provided.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4), udi#: (b)(4). Software analysis determined that the reported behavior was consistent with a known software anomaly. If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13004070
• MDR Text Key: 285825859
• Report Number: 1723170-2021-02887
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2021
• 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?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse