MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Device lot number, or serial number, unavailable.Udi not available for this system at time of filing.The device was not returned, so no analysis was conducted.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that when downloading an image the error message "unable to interpret image or header data medio io error" occurred.The manufacturer representative (mr) tried downloading the images with alternate module and error still occurred.The mr spoke with imaging on site who stating they followed the right protocol.The mr checked if the cd looks damaged and it wasn't.The site downloaded a new cd to see if that resolved the issue.There was no patient present when this issue was identified.Additional information revealed that the 3rd disc that was burned worked, the medtronic representative suspects it has something to do with how the site is burning their discs.However, the original discs were discarded.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through archive/image analysis.Analysis found that the probable cause of the issue could not be determined without further information.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the lot number, udi and device manufacture date were provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• Type of Device: EAR, NOSE AND THROAT 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8134465
• MDR Text Key: 129398780
• Report Number: 1723170-2018-06066
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1