FDA Adverse Event
Malfunction
Summary report: N
LANDMARX EVOLUTION
MDR report key: 2081188
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00843
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PER SOFTWARE INVESTIGATION, SOFTWARE BEHAVING AS DESIGNED, FRAME MOVED AFTER GOING STERILE. NO IMPACT ON PATIENT REPORTED.
Description of Event or Problem · 1
SITE REPORTED, THE HEAD FRAME MOVED DURING AN ENT SURGERY CAUSING A LOSS OF INSTRUMENT TRACKING, SURGEON RE-REGISTERED THE PT WITH TRACER AGAIN AND WAS ABLE TO CONTINUE. NO IMPACT ON PATIENT OUTCOME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANDMARX EVOLUTION | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | EVOLUTION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |