FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 1942044
·
Received November 9, 2010
Report
- Report Number
- 1723170-2010-00078
- Event Type
- Malfunction
- Date Received
- November 9, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 11, 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
PATIENT INFORMATION WAS UNAVAILABLE AT TIME OF THIS REPORT BUT HAS BEEN REQUESTED. DEVICE MANUFACTURE DATE HAS BEEN REQUESTED. SYSTEM INVESTIGATION IS ON-GOING AND RESULTS WILL BE REPORTED UPON COMPLETION.
Description of Event or Problem · 1
MEDTRONIC REPRESENTATIVE REPORTED SITE COMPLAINED OF INACCURACY WITH THEIR PENTERO/TREON INTERFACES. THEY FOCUS ON A POINT, TOUCH THE SAME POINT WITH A PROBE, THE SCOPE IS OFF BY ABOUT 5MM BUT THE PROBE IS ACCURATE. USE OF THE STEALTHSYSTEM WAS NOT ABORTED. NO IMPACT ON PATIENT OUTCOME.
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 | UNK |