FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2182241
·
Received July 12, 2011
Report
- Report Number
- 1723170-2011-01215
- Event Type
- Malfunction
- Date Received
- July 12, 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
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MFR. MEDTRONIC REP DISCUSSED WITH SURGEON THE POSSIBILITY OF THE VERTEK ARM MOVING WHEN SITE CHANGED ORIENTATION OF FRAME CAUSING THE INACCURACY. NO IMPACT ON PT OUTCOME REPORTED.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THE SITE WAS UNABLE TO GET GREEN CROSS HAIRS AFTER GOING STERILE. THE MEDTRONIC REP TROUBLESHOT WITH SITE AND SURGEON WAS INACCURATE AFTER CHANGING THE ORIENTATION OF FRAME. SURGEON DECIDED TO DISCONTINUE THE USE OF NAVIGATION BUT PROCEEDED WITH 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 | 64 YR |