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

Model Number 9735602

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 9735546, serial/lot #: unknown, ubd: unknown, udi#: unknown.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the electromagnetic localization box and navigation system were having intermittent communication issues.The system gets booted in different boot orders.It was indicated that the communication cable would be replaced.There was no patient involved.

Manufacturer Narrative

Other applicable components are: product id: 9735546, serial/lot #: (b)(4), ubd: unknown, udi# unknown.Unique device identifier (udi) is unavailable.The communication cable was returned to the manufacturer for analysis.Analysis found that the lemo connector of the returned cable is damaged in an out of round condition making it difficult to connect to the mating connector.Otherwise, the cable passed a continuity test with no opens or shorts detected.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The reported issue was confirmed.The electromagnetic communication cable was replaced.The system then passed a system checkout.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• 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: 9315473
• MDR Text Key: 178337353
• Report Number: 1723170-2019-05585
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

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: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 11/08/2019; 12/10/2019
• Supplement Dates FDA Received: 12/06/2019; 12/30/2019
• 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