FDA Adverse Event
Other
Summary report: N
STEALTHSTATION
MDR report key: 758975
·
Received September 5, 2006
Report
- Report Number
- 1723170-2006-00003
- Event Type
- Other
- Date Received
- September 5, 2006
- Date of Event
- August 8, 2006
- Report Date
- September 1, 2006
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER SYSTEM REC'D A NEW COMPUTER FOR THEIR EXISTING SYSTEM IN 11/05 - SOFTWARE LICENSE FOR THE KNEE SOFTWARE WAS MISTAKENLY NOT REACTIVATED AT INSTALL. AS THE STEALTHSTATION SYSTEM IS AN ADJUNCT TO SURGERY, THE FACT THAT IT WAS DISCOVERED UPON STARTUP THAT THE SYSTEM COULD NOT BE USED DURING THE KNEE SURGERY, ON THE DATE REFERENCED IN THE USER FACILITY REPORT, WOULD NOT HAVE ANY IMPACT ON PT SAFETY. MNAV FIELD STAFF REACTIVATED THE LICENSE AND TESTED THE SYSTEM TO ENSURE THAT THE SOFTWARE WAS ACCESSIBLE.
Description of Event or Problem · 1
NO DEATH, PT INJURY, OR MALFUNCTION ACTUALLY OCCURRED. CUSTOMER REPORT INVOLVED DISSATISFACTION WITH SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION | STEREOTACTIC SURGICAL SYSTEM | HAW | MEDTRONIC NAVIGATION, INC. | TRIA PLUS | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |