FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 1942051
·
Received November 9, 2010
Report
- Report Number
- 1723170-2010-00077
- 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
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION WAS NOT AVAILABLE AT TIME OF THIS REPORT, BUT HAS BEEN REQUESTED. SYSTEM INVESTIGATION IS ON-GOING AND RESULTS WILL BE REPORTED UPON COMPLETION.
Description of Event or Problem · 1
MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE FELT INACCURATE DURING A CASE WHERE THEY REGISTERED THE PATIENT WITH POINTMERGE AND SURFACE MERGE. THE DOCTOR PROCEEDED WITHOUT THE STEALTHSTATION. THERE WAS NO IMPACT TO PATIENT.
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 |