MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problem Imprecision (1307)

Patient Problems Cerebrospinal Fluid Leakage (1772); Brain Injury (2219); Iatrogenic Source (2498)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

On 04/22/2016: a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On 04/25/2016: the patient exams used for this surgery are no longer available on the system.No software analysis possible.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the surgeon alleged an inaccuracy.No further details regarding this issue, or specifically when it occurred, were provided.The patient was registered using tracer.A cerebrospinal fluid (csf) leak occurred.Following the leak they felt they were inaccurate by approximately 6 millimeters showing in anterior/inferior direction from true location.The surgeon spent just over an hour repairing the csf leak.The patient was re-registered using tracer and the surgeon alleged that the inaccuracy persisted.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was greater than one hour before continuing.There was no impact on patient outcome.

Manufacturer Narrative

Although the patient exams used for this surgery are no longer available on the system, a software investigation was completed and suspects the tracer pattern was the cause of the issue.Software is functioning as designed.The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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: 5640863
• MDR Text Key: 44725078
• Report Number: 1723170-2016-00037
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

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
• Device Catalogue Number: 9733560XOM
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2011
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 83