FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2021373
·
Received February 8, 2011
Report
- Report Number
- 1723170-2011-00096
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- 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
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT IN A SYNERGY CRANIAL CASE, THE REGISTRATION WAS FLIPPED L/R WITH TOUCH-N-GO. THE MEDTRONIC REP NOTED THAT THE FIDUCIALS WERE NOT SYMMETRICAL AND THEY SKIPPED AROUND WHEN TOUCHING THEM. THE SURGEON OPTED TO CONTINUE THE USE OF THE STEALTHSTATION TO COMPLETE THE SURGERY. 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 | 59 YR |