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 Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

Patient age not available.Udi not available for this system at time of filing.Other relevant device(s) are: product id: 9735638, software version: (b)(6).No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.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 a functional endoscopic sinus surgery (fess).It was reported that intra-operatively, there was a failed registration during an in office balloon procedure.After performing a trace registration, the trace pattern shifted superiorly approximately one centimeter and the registration failed.The trace registration was attempted multiple times after this with the same superior shift and failed registration.Point merge registration also failed with the third point on the patient's left eye.There was no movement of the patient tracker, accurate exam quality, and registration quality.Metal was removed from the field.There was a reported delay to the procedure of less than one hour due to this issue.Use of the navigation system and the procedure was aborted.There was no reported impact to patient outcome.

Manufacturer Narrative

Additional information: patient's age and additional information provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that the scans were high quality scans. the registration pattern the surgeon used was technically perfect.There was no metal interference. it was suspected that the issue was the equipment.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.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: 9139741
• MDR Text Key: 161338199
• Report Number: 1723170-2019-05054
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/01/2019; 01/07/2020
• Supplement Dates FDA Received: 10/28/2019; 01/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 91