FDA Adverse Event
Malfunction
Summary report: N
FUSION NAVIGATION SYSTEM
MDR report key: 2182402
·
Received July 11, 2011
Report
- Report Number
- 1723170-2011-01209
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MFR. RMA ISSUED FOR REPLACEMENT AXIEM BOX.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE PT TRACKER WOULD NOT INITIALLY TRACK WHEN THE SITE STARTED THEIR CASE. IN THE EMITTER TRACKING DETAILS, THE EMITTER WAS GREEN BUT THE AXIEM BOX WAS RED AND INDICATED IT WAS OVERHEATING AND SHOULD BE POWER CYCLED. WHEN THEY POWER CYCLED THE SYSTEM IT TRACKED THE PT TRACKER. THEY PROCEEDED WITH THE CASE BUT IT HAPPENED AGAIN IN THE MIDDLE OF NAVIGATING. NO IMPACT ON PT OUTCOME WAS REPORTED.
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 | UNK |