FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2050121
·
Received April 1, 2011
Report
- Report Number
- 1723170-2011-00573
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- August 13, 2010
- Report Date
- August 13, 2010
- 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
A SYSTEM CHECKOUT WAS PERFORMED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE, WHO ARCHIVED AND REMOVED THE SOFTWARE ERROR LOGS FROM THE COMPUTER. THERE HAVE BEEN NO FURTHER ISSUES REPORTED SINCE REMOVING THE ERROR LOGS. SYSTEM TESTED AND FOUND TO BE FULLY FUNCTIONAL.
Description of Event or Problem · 1
MEDTRONIC REPRESENTATIVE REPORTED SITE WAS ABLE TO ACQUIRE 10 ANTERIOR/POSTERIOR IMAGES. HOWEVER, WHEN THEY WENT TO ACQUIRE THE LATERAL IMAGE, THE SOFTWARE EXITED TO THE MAIN LOG IN SCREEN. REPRESENTATIVE STATED THAT THEY RE-BOOTED THE SYSTEM AND THE CASE CONTINUED AS PLANNED. THERE WAS NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |