FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2062505
·
Received March 21, 2011
Report
- Report Number
- 1723170-2011-00687
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
A MEDTRONIC ENT REP REPORTED THAT DURING A DEMO YESTERDAY (NO PT PRESENT) AT THE SITE, HE WAS IN THE FUSION SOFTWARE ON A ROLLINGSTONE COMPUTER AND THE SOFTWARE CRASHED WHILE AT THE "SELECT SURGEON" SCREEN. THE MEDTRONIC REP REPORTED THAT IT EXITED TO A BLACK SCREEN WITH WHITE BOOT TEXT. THEY THEN RE-STARTED THE SYSTEM AND WENT BACK INTO THE SOFTWARE - HE REPORTED THAT IT COMPLETELY FROZE (NO CURSOR MOVEMENT) AT THE "SELECT PATIENT" SCREEN. THEY RE-STARTED AND THE SYSTEM WORKED WITHOUT ISSUE FOR THE REST OF THE DEMO. THERE WAS NO PT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUSION NAVIGATION SYSTEM | STEREOTAXIC SYSTEM (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | FUSION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |