FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TRIA NAVIGATION SYSTEM
MDR report key: 2834288
·
Received November 15, 2012
Report
- Report Number
- 1723170-2012-00635
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 19, 2012
- Report Date
- October 19, 2012
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT WAS PRESENT AT THE TIME. MEDTRONIC INVESTIGATION FINDS A REQUEST FOR THE RETURN OF THIS ASSET. TO DATE, NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
A SITE REPRESENTATIVE, RN, REPORTED THE RIGHT REAR CASTER ON THE STEALTHSTATION TRIA NAVIGATION SYSTEM CAMERA CART FALLS OFF. NO PATIENT WAS PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TRIA NAVIGATION SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | TRIA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |