FDA Adverse Event
Malfunction
Summary report: N
STEALTH INAV PORTABLE SYSTEM
MDR report key: 2150766
·
Received June 21, 2011
Report
- Report Number
- 1723170-2011-01116
- Event Type
- Malfunction
- Date Received
- June 21, 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
PER RMA, A REPLACEMENT INAV PORTABLE SYSTEM WAS SENT TO SITE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE INAV BOOTED TO LOG-IN SCREEN AND ENTERED THE APPLICATION AND CAMERA WAS TRACKING FINE. THEY WERE ABLE TO VERIFY INSTRUMENTS AND REGISTER THE PT. THEN THE CAMERA STOPPED TRACKING THE CRANIAL REFERENCE FRAME. AFTER SOME TROUBLESHOOTING, THE SURGEON DISCONTINUED USE OF NAVIGATION TO COMPLETE THE PROCEDURE. NO IMPACT ON PT OUTCOME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTH INAV PORTABLE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | INAV PORTABLE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |