FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2081184
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00874
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- 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
PER RMA, A REPLACEMENT CAMERA WAS SENT TO SITE AND RESOLVED ISSUE. UPON EVALUATION OF RETURNED CAMERA, PASSIVE TRACKING WAS REDUCED TO LESS THAN 6 FEET AFTER WARM UP DURING A FUNCTIONAL TEST. THE PSU PASSED AN AAK TEST AT .38MM BUT WITH HIGH LINE SEPARATION. THE PSU PASSED SUBSEQUENT FUNCTIONAL AND AAK TESTS AND IS NOW FULLY FUNCTIONAL.
Description of Event or Problem · 1
SITE REPORTED THE CAMERA WAS NOT TRACKING THE INSTRUMENTS ON THE TREON NAVIGATION SYSTEM. NO IMPACT ON PATIENT 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 | 11 YR |