FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2081287
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00822
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- May 7, 2010
- Report Date
- May 7, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SOFTWARE INVESTIGATION FINDS THAT FIDUCIALS WHICH WERE PLACED SYMMETRICALLY CAUSED THE EXAM TO FLIP AFTER REGISTRATION. SITE HAS BEEN TRAINED ON PROPER FIDUCIAL PLACEMENT. SOFTWARE BEHAVING AS DESIGNED.
Description of Event or Problem · 1
SITE CALLED IN TO REPORT THEY VERIFIED THE EXAM ORIENTATION PROPERLY, AND AFTER COMPLETING A TOUCH N GO REGISTRATION ON THE TREON SYSTEM, THE PROBE DISPLAYED A FLIPPED LEFT/RIGHT ORIENTATION. SITE THEN COMPLETED A POINT MERGE REGISTRATION AND THEY WERE ABLE TO NAVIGATION ACCURATELY AND COMPLETE SURGERY. NO IMPACT ON PT OUTCOME REPORTED.
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 |