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

Model Number FUSION COMPACT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paresis (1998); Iatrogenic Source (2498)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age and weight were not made available from the site, citing legal/confidential concerns.Device manufacturing date is unavailable.System analysis finds this is not a software complaint and system check-out passed successfully.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's fusion compact navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

A medtronic representative received a report that two days following an ear, nose & throat (ent) procedure, it was noted there was an issue with a patient.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.It was reported that the patient was raised from the anesthesia after the surgery and found to have issues to move his left arm from wrist.It was reported that there was apparently nerve damage on the arm.There was a medtronic navigation system in the operating room (or).Set-up was built for the surgeon to operate from right side of the patient.Emitter and hand support were on the left side of the patient.After set-up was built, and patient was on anesthesia, it happened that surgeon changed and she was left-handed and had to operate from another side, same side as emitter and hand support.Fusion emitter stand was on the same side.The emitter was connected to the bed rail with the mobile emitter arm and clamp.As the bed rail was short and the mobile emitter arm was coming close to the patient, the site used stuffing between arm and patient.The site stated that the injury was not directly related to use of navigation.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy reported.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's fusion compact navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Additional information: patient age and weight provided.As previously reported there was no problem with the navigation equipment, and this event should have been reported as an adverse event only.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6001968
• MDR Text Key: 56535658
• Report Number: 1723170-2016-02460
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 83