FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2081213
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00801
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 12, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC REP CLEANED THE CAMERA CONNECTION AND RESOLVED THE ISSUE. NO PARTS WERE REPLACED.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED DEFECTIVE CABLE ON THE CAMERA. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.
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 |