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

Catalog Number 9735665

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identification (udi) unavailable.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure while the site was setting up for a biopsy that they could not adjust the cone of reachability.The site was using a mouse and the hand icon would not appear.When the site clicked in the box and dragged up and down, the software would zoom in and out with the left and right mouse buttons.Touching the screen would not adjust it either.The site stepped back out of the software and then forward into the software, and then they were able to adjust the cone.No patient was present.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7659816
• MDR Text Key: 113261627
• Report Number: 1723170-2018-03086
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• 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