FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2062251
·
Received April 12, 2011
Report
- Report Number
- 1723170-2011-00776
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT WEIGHT NOT AVAILABLE FROM SITE. INVESTIGATION IS CURRENTLY IN PROGRESS.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN THEY TRIED TO ACQUIRE IMAGES FOR FLUOROMERGE, AN ERROR MESSAGE APPEARED ABOUT BAD IMAGE QUALITY. THE LATERAL IMAGE COULD NOT BE ACTIVATED. THEY TRIED A NEW WIRELESS TRACKER AND HAD THE SAME PROBLEM. THE HOSPITAL THEN REMOVED THE S7 SYSTEM AND BROUGHT IN THEIR TREON SYSTEM TO DO THE CASE.
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 | 46 YR |