FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2182409
·
Received July 11, 2011
Report
- Report Number
- 1723170-2011-01208
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 22, 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
DEVICE MFR DATE UNAVAILABLE AT TIME OF THIS REPORT. RMA ISSUED FOR BULKHEAD CONNECTOR REPLACEMENT.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE STEALTHSTATION TREON WOULD NOT COMMUNICATE WITH THE O-ARM DURING A CASE. THEY WALKED THROUGH TROUBLE-SHOOTING, TRYING MULTIPLE NETWORK CABLES, RE-BOOTING AND USING AN ALTERNATE STEALTHSTATION TREON SYSTEM WITH THE O-ARM, HOWEVER, THEY WERE STILL UNABLE TO ESTABLISH COMMUNICATION. THE SURGEON DISCONTINUED USE OF NAVIGATION FOR THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A C-ARM. THE MEDTRONIC REP THEN REPORTED THAT THE NETWORK CONNECTOR ON THE SIDE OF THE SYSTEM WAS BROKEN. NO IMPACT ON THE PT OUTCOME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |