FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2211931
·
Received August 10, 2011
Report
- Report Number
- 1723170-2011-01279
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 22, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
A MEDTRONIC ENT REPRESENTATIVE REPORTED A 2 MM INACCURACY, AT THE TIP OF THE NOSE, AFTER REGISTRATION IN AN ENT PROCEDURE. THE SURGEON CONFIRMED THAT THE TRACER PATTERN DID NOT INCLUDE ANY SOFT TISSUE AND THAT THE 3D MODEL LOOKED AND DID NOT INCLUDE ANY ARTIFACT OR SCATTER. FOLLOWING TROUBLESHOOTING WITH A MEDTRONIC REPRESENTATIVE, THE SURGEON DISCONTINUED USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.
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 | 50 YR |