FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2862477
·
Received December 10, 2012
Report
- Report Number
- 1723170-2012-00690
- 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
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE DOCUMENTED INVESTIGATION OF THIS COMPLAINT, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.
Additional Manufacturer Narrative · 1
NO FILES HAVE BEEN RECEIVED BY MANUFACTURER FOR EVALUATION TO DATE. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT WHILE IN AN ENT PROCEDURE, THE SYSTEM BECAME APPROXIMATELY 3 TO 4MM INACCURATE. THIS WAS NOTED AFTER CHANGING INSTRUMENTS AND CHECKING ACCURACY ON THE BRIDGE AND TIP OF THE PATIENT NOSE. THE SURGERY WAS COMPLETED WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO NEGATIVE IMPACT ON THE 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 | 62 YR |