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

Model Number 9733560XOM

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the power cable for the navigation system was replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.The power cable was returned to the manufacturer for evaluation.Testing found that the power cable had an open in a brown wire in the cable.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Other relevant device(s) are: product id: 9733678, serial/lot #: (b)(4).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 of a procedure.It was reported that the power cord was bent for an extended time and the system was having power issues due to the damage over time.There was no patient present at the time of the time of the event.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• 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: 8983340
• MDR Text Key: 157362836
• Report Number: 1723170-2019-04827
• Device Sequence Number: 1
• Product Code: HAW
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2019
• 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