FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT FUIDANCE SYSTEM
MDR report key: 2191533
·
Received July 20, 2011
Report
- Report Number
- 1723170-2011-01238
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 30, 2011
- Report Date
- June 30, 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
SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT DURING A CRANIAL SURGERY, THE SURGEON WAS UNABLE TO REALIGN REGISTRATION DUE TO CHECK-POINTS NO LONGER BEING VISIBLE IN THE FIELD AS THE SURGEON HAD MOVED THE REFERENCE FRAME. THE STEALTHSTATION TREON GUIDANCE SYSTEM HAD SHOWN HIM HIS ENTRY POINT AND TRAJECTORY. THE TUMOR WAS SUPERFICIAL SO THE SURGEON DECIDED TO PROCEED WITH THE CASE WITHOUT NAVIGATION. NO IMPACT ON THE PT OUTCOME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT FUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |