FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2150813
·
Received June 21, 2011
Report
- Report Number
- 1723170-2011-01127
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 27, 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
SOFTWARE INVESTIGATION FINDS THE REP. HAD DOWNGRADED FROM SYNERGY SPINE 2.0 TO 1.7 WITHOUT FIRST REMOVING 2.0. THIS IS NOT A SUPPORTED PROCEDURE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THE SITE TOOK AP AND LATERAL IMAGES IN A FLUOROSCOPIC NAVIGATED CASE. WHEN THEY WENT TO NAVIGATE, THE QUADRANTS WERE BLANK. WHEN ATTEMPTING TO CHANGE THE IMAGES IN THE VIEWS, THE SYSTEM EXITED AND STAYED IN THAT STATE FOR 3 MINUTES. THEY DID A HARD SHUT DOWN AND RE-BOOTED. THE SURGEON OPTED TO DISCONTINUE THE USE OF THE STEALTHSTATION S7 NAVIGATION SYSTEM. NO IMPACT ON THE PT'S OUTCOME WAS REPORTED.
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 | 66 YR |