FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2150564
·
Received June 22, 2011
Report
- Report Number
- 1723170-2011-01132
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 26, 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
MEDTRONIC REPRESENTATIVE COULD NOT REPLICATE THE ISSUE. INVESTIGATION FINDS NAVIGATION SYSTEM CHECKED OUT SUCCESSFULLY. NO FURTHER ISSUES REPORTED.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE STEALTHSTATION TREON NAVIGATION SYSTEM FROZE BEFORE ATTEMPTING TO DO A REGISTRATION. THE SITE CLICKED ON THE BACK BUTTON AND NOTHING HAPPENED; THEY WERE UNABLE TO CLICK ON ANYTHING ELSE. THE SYSTEM THEN UNFROZE; WENT BACK SEVERAL STEPS IN THE SOFTWARE AND THEY WERE ABLE TO EXIT THE APPLICATION. THE SURGEON WAS ABLE TO RE-OPEN THE APPLICATION TO COMPLETE THE SURGERY SUCCESSFULLY AND EVERYTHING WORKED PROPERLY. THERE WAS NO IMPACT ON THE PATIENT OUTCOME WAS REPORTED.
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 | 70 YR |