FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TRIA NAVIGATION SYSTEM
MDR report key: 1961668
·
Received December 28, 2010
Report
- Report Number
- 1723170-2010-00230
- Event Type
- Malfunction
- Date Received
- December 28, 2010
- Date of Event
- June 14, 2010
- Report Date
- June 14, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PT INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE COMPUTER WAS RETURNED TO THE MFR FOR EVAL. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM WAS FULLY FUNCTIONAL AND PASSED ALL TESTS.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THERE WAS A SEVEN MINUTE DELAY BEFORE AN ENT CASE DUE TO BLACK SCREEN PRIOR TO THE START OF SURGERY. AFTER REBOOTING THE SYSTEM TWICE, THE SURGERY CONTINUED USING THE SEALTHSTATION WITH NO IMPACT ON PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TRIA NAVIGATION SYSTEM | STEREOTAXIC SURGICAL SYSTEM (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | TRIA | 793821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |