FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2045278
·
Received February 28, 2011
Report
- Report Number
- 1723170-2011-00259
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 25, 2010
- Report Date
- February 25, 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
MEDTRONIC REP TESTED SYSTEM AND PROBE THAT WAS INACCURATE, THE TOUCH N GO PROBE PERFORMED AS INTENDED. MEDTRONIC REP REVIEWED WITH SURGEON HOW TO REGISTER WITH TOUCH N GO. SOFTWARE INVESTIGATION COMPLETED, DETERMINED THE SOFTWARE WAS BEHAVING AS DESIGNED.
Description of Event or Problem · 1
SITE CALLED TO REPORT A HALF-INCH INACCURACY AFTER SURGEON REGISTERED WITH THE TOUCH N GO PROBE. SURGEON RE-REGISTERED THE PT WITH POINTMERGE AND ACHIEVED ACCURACY. THE CASE CONTINUED WITH NAVIGATION AFTER A SUCCESSFUL POINTMERGE REGISTRATION WITH NO IMPACT TO THE PT.
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 | UNK |