FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION IOR SYSTEM
MDR report key: 2597100
·
Received May 31, 2012
Report
- Report Number
- 1723170-2012-00272
- Event Type
- Malfunction
- Date Received
- May 31, 2012
- Date of Event
- April 25, 2012
- Report Date
- May 4, 2010
- 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
PT WEIGHT IS UNAVAILABLE FROM THE SITE. SOFTWARE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT DURING A POSTERIOR FOSSA TUMOR REMOVAL, NAVIGATION WAS ALLEGEDLY 1/2 CM INACCURATE. ACCORDING TO THE SURGEON, HE WAS "1/2 CM" SHALLOW OF THE TUMOR, AT THE TIME THE DISPLAY SHOWED HIM THE TUMOR. SURGEON WAS ABLE TO TAKE AN INTRA-OPERATIVE MRI AND SUCCESSFULLY COMPLETE THE CASE WITHOUT USING NAVIGATION. NO HARM TO THE PT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION IOR SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | IOR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |