FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2081276
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00845
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- August 6, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC REP TESTED THE SYS AND COMMUNICATED TRACER AND FIDUCIAL REGISTRATION TIPS TO SURGEON TO IMPROVE HIS NEXT REGISTRATION.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED, DURING SURGERY, THE SURGEON WAS INACCURATE AFTER USING POINTMERGE AND TRACER REGISTRATION METHODS. THE REP STATED THAT THE FIDUCIALS WERE PLACED ON TOP OF THE HAIR OR ON SOFT TISSUE AND ANOTHER WAS DEPRESSED WITH TAPE. ALSO, THE SURGEON TRACED A SMALL AREA ON THE FOREHEAD AND TOP OF THE HEAD AND DID NOT TRACE ALONG THE BRIDGE OF THE NOSE. SURGEON CONTINUED WITH NAVIGATION. NO IMPACT ON PT OUTCOME WAS REPORTED.
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 |