FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2081259
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00831
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- July 12, 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
PER RMA A REPLACEMENT CAMERA WAS SENT TO SITE. UPON INVESTIGATION OF THE RETURNED CAMERA, TRACKING WAS FOUND TO BE NORMAL DURING A FUNCTIONAL TEST. THE PSU PASSED AN AAK TEST. NO PROBLEM FOUND. DID NOT CAUSE EVENT.
Description of Event or Problem · 1
MEDTRONIC REP CALLED TO REPORT THE SURGEON WAS 1 CM INACCURATE WITH THE APT AND PROBES WHEN USING THE TREON SYS FOR A SPINE PROCEDURE. SURGEON CONTINUED WITH NAVIGATION. 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 | O-ARM 1000 IMAGING SYSTEM. |