FDA Adverse Event
Malfunction
Summary report: N
LANDMARX ELEMENT
MDR report key: 2020439
·
Received February 8, 2011
Report
- Report Number
- 1723170-2011-00092
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SOFTWARE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE TRACER REGISTRATION WOULD COMPLETE BUT BE INACCURATE 2-3 CM USING LANDMARX ELEMENT. THEY COMPLETED A POINT MERGE REGISTRATION, AND WAS STILL ABOUT 2 CM INACCURATE. THE SURGEON COMPENSATED FOR THE INACCURACY AND FINISHED THE CASE USING THE SYSTEM. THERE WAS NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANDMARX ELEMENT | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | ELEMENT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |