FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION IOR SYSTEM
MDR report key: 4277584
·
Received November 25, 2014
Report
- Report Number
- 1723170-2014-01281
- Event Type
- Malfunction
- Date Received
- November 25, 2014
- Date of Event
- October 31, 2014
- Report Date
- October 31, 2014
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.
Additional Manufacturer Narrative · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE TOOL INTERFACE UNIT (TIU) WAS REPLACED ON 12/09/2014 AND THE SYSTEM WAS WORKING FINE. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED A SITE NAVIGATION SYSTEM CAMERA THAT WAS DISPLAYING BLACK STATUS INTERMITTENTLY. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763993 | STEALTHSTATION IOR SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | IOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |