FDA Adverse Event
Malfunction
Summary report: N
LANDMARX ELEMENT OR ENT
MDR report key: 2182253
·
Received July 12, 2011
Report
- Report Number
- 1723170-2011-01214
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 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
PARTS NOT RETURNED TO MFR.
Description of Event or Problem · 1
A MEDTRONIC ENT REP REPORTED THE SURGEON FELT INACCURATE TO THE LEFT WITH THE TRACER REGISTRATION. AS THE SURGEON BROUGHT THE SHAVER INTO THE FIELD, IT WAS VERIFIED OFF ON NAVIGATION. THE SURGEON DISCONTINUED THE USE OF THE NAVIGATION. NO IMPACT ON PT OUTCOME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANDMARX ELEMENT OR ENT | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | ELEMENT OR ENT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |