FDA Adverse Event
Other
Summary report: N
STEALTHSTATION TREON PLUS
MDR report key: 935688
·
Received November 1, 2007
Report
- Report Number
- 1723170-2007-00008
- Event Type
- Other
- Date Received
- November 1, 2007
- Date of Event
- September 25, 2007
- Report Date
- October 22, 2007
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K971247
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS EVENT IS STILL IN PROGRESS. NO CONCLUSIONS HAVE BEEN MADE TO-DATE AS TO THE LIKELIHOOD THAT ANY MATERIAL COULD BE TRANSFERRED TO THE PATIENT OR RESULTANT LONG-TERM EFFECTS.
Description of Event or Problem · 1
AFTER CRANIAL BIOPSY, PIECES OF PLASTIC WERE OBSERVED ON THE SPECIMEN UPON EXTRACTION OF SAID SPECIMEN FROM THE PASSIVE BIOPSY NEEDLE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON PLUS | STEREOTAXIC SURGICAL SYSTEM | HAW | MEDTRONIC NAVIGATION, INC. | 9733068 | 066115607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |