FDA Adverse Event
Injury
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2050833
·
Received April 1, 2011
Report
- Report Number
- 1723170-2011-00515
- Event Type
- Injury
- Date Received
- April 1, 2011
- Date of Event
- September 15, 2010
- Report Date
- September 15, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYS WAS FULLY FUNCTIONAL AND SHOWS NO ANOMALIES.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT A SITE WAS 1 CM. INACCURATE DURING A CRANIAL CASE USING POINTMERGE. IT WAS STATED THAT THE SURGEON DOESN'T CHECK ANATOMICAL LANDMARKS WHEN CHECKING ACCURACY BUT GLIDES THE PROBE ACROSS THE HEAD. THE SURGEON FOUND THE TUMOR AND FOUND IT NECESSARY TO ENLARGE THE BONE FLAP SLIGHTLY TO FULLY COMPLETE THE SURGERY.
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 | Required Intervention |