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

Model Number 9735665

Device Problems Mechanical Problem (1384); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system used outside of a procedure.It was reported that the site had just upgraded their software the week prior to the event.Since the update, when the site tests their connection with electronic picture archiving and communication systems (pacs) via a blank query, the system becomes unresponsive.They were able to use this method prior to the new software installation.The site also saw a low memory error at one point.When a filter is added, then they are able to query.It was recommended to the have the site check with their electronic picture archiving and communication systems (pacs) to determine if they have "only query" enabled now that the port handles both functions.There was no patient involvement in this event.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through known anomaly determination.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: additional information and initial reporter provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that the system was working without issue.For the first week, the site had to apply a filter to get the system to work but now they were waiting a little longer before attempting and the system was working without issue.

• 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: 8495676
• MDR Text Key: 141342850
• Report Number: 1723170-2019-01620
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 04/09/2019; 07/15/2019
• Supplement Dates FDA Received: 04/26/2019; 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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