FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2062537
·
Received March 21, 2011
Report
- Report Number
- 1723170-2011-00691
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT AGE NOT AVAILABLE AT THIS TIME. SOFTWARE INVESTIGATION IN PROGRESS.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THERE WAS 2-4MM INACCURACY ANTERIOR WITH BOTH THE REGISTRATION POINTER AND STYLET ONCE THE PATIENT WAS DRAPED. THE SURGEON COMPLETED A GOOD REGISTRATION AND VERIFIED ITS ACCURACY. THEY REMOVED ALL SOURCES OF METAL IN THE FIELD. THE MEDTRONIC REPRESENTATIVE WAS TOLD THERE WAS A WARNING MESSAGE: INTERNAL TEMPERATURE HIGH. THE CRANIAL SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PATIENT 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 | UNK |