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

Model Number 9735602

Device Problems Electrical /Electronic Property Problem (1198); Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device serial number and udi number, unavailable.The compact fusion system, axiem box, and the emitter were replaced on site.The system then was observed to operate as intended.No parts were received for analysis, as parts were lost in transit.Cause unable to be established.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that the device had an electric shortage from a faulty power cable.This was noticed outside of procedure.There was a spark and burn smell, and it was not possible to turn on the device again.Only the axiem box turned on, but blinked green.The system, axiem box, and emitter were replaced.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: the system was returned to the manufacturer for analysis.Analysis found that when connected to ac, the computer would not power up.Analysis found that the reported event was related to an electrical issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received conflicting information that the axiem box and emitter were not replaced.Follow-up is being conducted.

Manufacturer Narrative

The computer was sent to the vendor for analysis.Vendor analysis found that the unit would not power on.It was noted that the unit was run through production process.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the total system had been replaced for the customer including the emitter and axiem box.It was noted that only the compact pc was shipped back because the emitter and instrument box were tested with another working system and they were fine.It was noted that once a replacement pc was received the system would be used as a demo.

• Brand Name: FUSION COMPACT
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8286749
• MDR Text Key: 134454571
• Report Number: 1723170-2019-00445
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• 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: 09/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• 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: Unknown
• Patient Sequence Number: 1