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

Model Number 9735602

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while outside of a procedure, the portable electromagnetic interface could not be recognized by the navigation system.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the electromagnetic interface system of the navigation system was replaced.The system then passed the system checkout and was found to be fully functional.The unit has not been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The electromagnetic interface system for the navigation system was returned to the manufacturer for analysis.The unit was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT 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: 7919486
• MDR Text Key: 122157360
• Report Number: 1723170-2018-04930
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2018
• 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: Unknown
• Patient Sequence Number: 1