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

Model Number FUSION COMPACT

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight not made available from the site.Device manufacturing date is unavailable.On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Return requested.Replacement mobile field generator and portable axiem both shipped to site (b)(4) 2016.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A site surgeon reported that, while in the beginning of a functional endoscopic sinus surgery (fess), the patient was registered successfully.In the middle of the surgery, their navigation system stopped navigating and in the emitter details, all lines were red and showed errors.The navigation system was re-booted and all trouble-shooting was done, however, the issue was not resolved.The surgeon chose to abandon the use of navigation.The surgeon opted to continue and completed the procedure without the use of the navigation system and without the imaging system.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

Correction to: procode, common device name, brand name, catalog number, and model mber now provided.Correction to 510k now provided.Device manufacturing date now provided.

Manufacturer Narrative

Investigation of returned suspect field generator (emitter) finds that the reported problem could not be duplicated.The field generator was connected to a test system for a five hour burn-in test.The system remained in green status during all testing.It passed the accuracy test with an error of 1.256mm.Flexing the cable does not indicate any intermittent opens.The device was found to be fully functional with no problem found.Investigation of returned suspect axiem portable confirmed the reported problem was caused by an electrical failure.The axiem unit was connected to a test system with the ent application.Test system reported that the axiem box, and emitter was showing a communication error.Under transmitter coil drivers at over current em interface reported a fault on amp c.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.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5870669
• MDR Text Key: 51938825
• Report Number: 1723170-2016-02071
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/12/2016; 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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 Age: 63 YR