FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2193629
·
Received July 13, 2011
Report
- Report Number
- 1723170-2011-01222
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PATIENT WEIGHT IS UNAVAILABLE FROM THE SITE AT THE TIME OF THIS REPORT. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
A REGISTERED NURSE REPORTED AN INCOMPLETE IMAGE TRANSFER FROM O-ARM TO TREON DURING A SPINE CASE. SHE STATED THAT AFTER TAKING AN O-ARM SPIN, THE IMAGES LOOKED GOOD ON THE MOBILE VIEWING STATION (MVS) MONITOR BUT APPEARED TO BE TRUNCATED ON THE TRAJECTORY VIEWS IN SYNERGY SPINE ON THE STEALTHSTATION TREON GUIDANCE SYSTEM. NO IMPACT ON PATIENT OUTCOME WAS 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 | 73 YR | O-ARM 1000 IMAGING SYSTEM |