FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2062204
·
Received April 12, 2011
Report
- Report Number
- 1723170-2011-00773
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 16, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM HAS BEEN USED SUCCESSFULLY WITHOUT ISSUE SINCE THIS OCCURRED. AN IN HOUSE SOFTWARE INVESTIGATION INTO THE ROOT CAUSE IS ONGOING.
Description of Event or Problem · 1
A SITE REP REPORTED THAT DURING A CRANIAL SURGERY, THEY EXPERIENCED A COMMUNICATION FAILURE WITH THE STEALTHSTATION. THE NAVIGATION TASK DISPLAYED AN ERROR THAT READ "COMMUNICATION FAILURE: THE APPLICATION HAS DETECTED A COMMUNICATION FAILURE AND NEEDS TO LOGOUT TO REESTABLISH THE CONNECTION." THE SITE REP CLICKED OK AND THIS WOULD BRING HER TO A BLACK SCREEN WITH TEXT THAT READ "GEMOS-V009 LOGIN:" SHE THEN RE-BOOTED THE SYSTEM AND THIS TEMPORARILY RESOLVED THE ISSUE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |