FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2983500
·
Received February 28, 2013
Report
- Report Number
- 1723170-2013-00144
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- February 20, 2013
- Report Date
- February 20, 2013
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE SURGEON DECIDED TO CONTINUE THE PROCEDURE WITH THE KNOWLEDGE OF THE INACCURACY. SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.
Additional Manufacturer Narrative · 1
THE TRACER PATTERN WAS ANALYZED BY A MEDTRONIC REPRESENTATIVE AND FOUND TO BE SUBOPTIMAL. SYSTEM WAS CHECKED OUT ON SITE BY A MEDTRONIC FIELD REPRESENTATIVE AND PASSED ALL TESTING. NO FAULT FOUND WITH SOFTWARE OR HARDWARE.
Description of Event or Problem · 1
A MEDTRONIC ENT REPRESENTATIVE REPORTED A 2-3 MM INACCURACY, ON PATIENT'S RIGHT SIDE, THAT OCCURRED DURING THE NAVIGATION STEP OF A FRONTAL ENDOSCOPIC SINUS SURGERY (FESS). THE SURGEON OPTED TO CONTINUE AND COMPLETE THE PROCEDURE WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86568 | FUSION NAVIGATION SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | FUSION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |