FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2063231
·
Received March 22, 2011
Report
- Report Number
- 1723170-2011-00697
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION NOT AVAILABLE AT TIME OF THIS REPORT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED LOST COMMUNICATION WITH THE STEALTHSTATION CAMERA. IT WAS REPORTED THAT WHEN THE SYSTEM IS LEFT FOR A WHILE (DURING DRAPING RIGHT AFTER TRACER), THE COMPUTER HANGS AND THE CUSTOMER NEEDS TO RESTART THE WHOLE STATION. THERE WAS NO PATIENT IMPACT.
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 | UNK |