FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2240837
·
Received August 16, 2011
Report
- Report Number
- 1723170-2011-01291
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 22, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE MFR DATE UNAVAILABLE AT TIME OF THIS REPORT. SOFTWARE INVESTIGATION COMPLETED, THE MEDTRONIC REP COULD NOT REPLICATE THE ISSUE. INSUFFICIENT INFO TO DETERMINE ROOT CAUSE. SYSTEM IS REPORTED TO BE PERFORMING AS DESIGNED. NO FURTHER ISSUES REPORTED.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED A SOFTWARE FREEZE THAT OCCURRED WHILE THE SITE WAS TRYING TO EXIT THE SYNERGY SPINE 2.0 APPLICATION. THE EXIT BUTTON WAS SELECTED, THE SCREEN THEN FROZE AND BECAME DISTORTED, EVERYTHING ON THE DISPLAY APPEARED FUZZY. THE SITE PERFORMED A HARD BOOT-DOWN TO POWER OFF THE SYSTEM. THE EVENT OCCURRED AFTER THE CASE WAS COMPLETE, NO PT WAS PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |