FDA Adverse Event
Summary report: N
MEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBE
MDR report key: 3250764
·
Received July 25, 2013
Report
- Report Number
- 3250764
- Date Received
- July 25, 2013
- Date of Event
- July 11, 2013
- Report Date
- July 25, 2013
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ETN
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
EMG ENDOTUBE USED TO MONITOR RECURRENT LARYNGEAL NERVE SIGNAL LATENCIES. TUBE FAILED TO PICK UP SIGNALS FROM ONE SIDE. THE PATIENT WAS RE-STIMULATED SEVERAL TIMES, BUT THIS FAILED. AND AS A RESULT, THE PATIENT HAD TO BE REINTUBATED WITH A NEW EMG ENDOTUBE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THYROIDECTOMY AND PARATHYROIDECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349342 | MEDTRONIC XOMED NIM EMG ENDOTRACHEAL TUBE | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED INC. | * | 0206105416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |