FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2092154
·
Received April 27, 2011
Report
- Report Number
- 1723170-2011-00914
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. FURTHER INVESTIGATION FINDS THIS IS AN ISOLATED ISSUE WHICH WAS RESOLVED WITH FURTHER ON-SITE TRAINING. SYSTEM OPERATING NORMALLY.
Description of Event or Problem · 1
A MEDTRONIC ENT REPRESENTATIVE REPORTED INTERMITTENT INACCURACIES WITH VARIOUS PROBES WHILE IN AN ENT PROCEDURE. AS REPORTED, "SOMETIMES THEY'RE DEAD ON, SOMETIMES THEY'RE NOT." IT IS UNKNOWN WHETHER THE INSTRUMENTS TRACK CORRECTLY IN ONE AREA AND TRACK POORLY IN ANOTHER OR INTERMITTENTLY TRACK POORLY IN THE SAME AREA. ONLY ONE SURGEON IS EXPERIENCING THIS ISSUE AT THE SITE. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUSION NAVIGATION SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | FUSION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |