FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2182239
·
Received July 12, 2011
Report
- Report Number
- 1723170-2011-01219
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Date of Event
- June 28, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MFR.
Description of Event or Problem · 1
A SURGEON REPORTED THAT HE RECEIVED ERRORS FOR HIS TRAJECTORY AS THE ENTRY POINT WAS INFERIOR TO TARGET ON THE TREON NAVIGATION SYSTEM WITH THE FRAMLINK5 SOFTWARE. BACK IN THE SOFTWARE, HE REGISTERED THE STEREOTACTIC LOCALIZER IN THE REVERSE DIRECTION AND WAS THEN ABLE TO RECEIVE FRAME SETTINGS. THE SURGEON REALIZED THAT THE SETTINGS WERE NOT VALID AND DID NOT USE THE ENTRY POINT SETTINGS FOR HIS PROCEDURE. NO IMPACT ON PT 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 | 41 YR |