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

Model Number 9733560XOM

Device Problem Human-Device Interface Problem (2949)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733467 (software version: 2.3).A medtronic representative went to the site to test and service the equipment.The navigation system passed the system checkout and was found to be fully functional.No hardware parts were replaced on the system.A software analysis was also completed utilizing a design analysis methodology.The software analysis found that the behavior described is the intended behavior of the software.It was determined that the software was functioning as designed.Device manufacturing date 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 for a functional endoscopic sinus surgery (fess).It was reported that the tools 7 was missing from the navigation system.A new computer was installed in the navigation system, but it did not have the tools 7 disc installed on it after the original computer was replaced.The site discovered this during a clinical case when they found that the non-invasive patient tracker (nipt) was not available.The site had to cancel the case and abort the surgery as a result.Anesthesia had been administered to the patient prior to the surgery being aborted, but an incision had not been made prior to the surgery being aborted.It was noted that there was a delay to the procedure.The surgery was rescheduled and took place 2 weeks later; it was completed without complication.No symptoms were experienced by the patient except for a delay in surgical intervention.The impact on patient outcome was minimal.It was later reported that a medtronic representative confirmed that he installed the tools 7 disc with resolution.

Manufacturer Narrative

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

Event Description

Additional information was received.Once the surgeon realized that he could not register the patient due to ¿unrecognized patient tracker¿ he aborted the procedure.It was estimated that the patient was asleep for 25 minutes before the decision was made to abort.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• 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: 8860867
• MDR Text Key: 153269916
• Report Number: 1723170-2019-04369
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2019

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: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/25/2019
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 76