FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2862510
·
Received December 10, 2012
Report
- Report Number
- 1723170-2012-00691
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT THE METAL RETRACTORS WERE CAUSING INTERFERENCE IN THE EM FIELD. THE SOFTWARE IS FUNCTIONING AS DESIGNED.
Description of Event or Problem · 1
A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT WHILE IN AN ENT PROCEDURE, THERE WAS AN INACCURACY WITH THE EMITTER. AFTER TROUBLESHOOTING, IT WAS DETERMINED THERE WERE MULTIPLE SOURCES OF METAL INTRODUCED IN THE FIELD AND OTHER SOURCES OF INTERFERENCE CAUSING THE ISSUE. THE SURGEON OPTED TO DISCONTINUE TROUBLESHOOTING AND THE USE OF THE FUSION NAVIGATION SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUSION NAVIGATION SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | FUSION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |