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

Catalog Number 9735665

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The archive used in the procedure was sent to medtronic for evaluation.The archive was found to have two touch points for registration and a passing registration.It was noted that the zone of accuracy encompassed the sinus that was being operated on.

Event Description

A medtronic representative reported that, while in a nasal skull base repair procedure, the site was able to place a shunt without issue.However, when attempting to add ent instruments into the cranial application software for the second portion of the procedure.It was then noticed by the representative that three ports on the interface box were not functioning.It was reported that the site could then not complete registration though the patient tracker was functioning.The representative then entered the ear, nose & throat (ent) application software without resolution as the probe could not be verified.The side emitter was then used without resolution.Functionality was restored as the instrument could eventually be performed.However, intermittent tracking was then noted when in the nav panes.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

The logs for the navigation system were evaluated by medtronic personnel.The logs showed that the instrument had a high geometry error, indicating that there was possibly metal interference.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7074704
• MDR Text Key: 93698578
• Report Number: 1723170-2017-04904
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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: 38 YR
• Patient Weight: 134