FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2152937
·
Received June 17, 2011
Report
- Report Number
- 1723170-2011-01102
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K001284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC REPRESENTATIVE REPLACED THE EMITTER AT THE SITE WHICH CORRECTED THE PROBLEM. RMA ISSUED FOR PROBLEM EMITTER.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAD ISSUES DURING AN ENT SURGERY WITH ALL INSTRUMENTS NOT REGISTERING IN NAVIGATION. THE SITE WAS ABLE TO USE THE REGISTRATION PROBE AND PERFORM TRACER. TRACER REGISTRATION WAS OFF BY 3MM HIGH. THE MEDTRONIC REPRESENTATIVE INSTRUCTED THE SITE TO RE-DO REGISTRATION AND ACCURACY WAS OFF BY 3MM TO THE RIGHT. THE DISTANCE TO DIVOT ERROR WAS 2.4; GEOMETRY ERROR NOT KNOWN. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUSION NAVIGATION SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | FUSION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |