FDA Adverse Event
Malfunction
Summary report: N
LANDMARX EVOLUTION
MDR report key: 2191547
·
Received July 20, 2011
Report
- Report Number
- 1723170-2011-01234
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 28, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RMAS ISSUED. INVESTIGATION FINDS THE POSITION SENSOR UNIT (PSU) DID NOT REPLICATE THE REPORTED BEHAVIOR OF CONSTANT BEEPING, AND WAS FOUND TO HAVE A REDUCED TRACKING VOLUME AFTER WARM-UP. TRACKING THROUGH THE VOLUME WAS INCONSISTENT AND WAS NOT ABLE TO COMPLETE AN AAK TEST. THE SYSTEM FROZE RANDOMLY AND STOPPED TRACKING BEFORE RETURNING TO NORMAL TRACKING. A SECOND FUNCTIONAL TEST AND ATTEMPTED AAK TEST CONFIRMED THE INITIAL RESULTS.
Description of Event or Problem · 1
A SITE REP REPORTED A LOUD, CONTINUOUS BEEPING SOUND COMING DIRECTLY FROM THE SYSTEM CAMERA. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.
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 |