FDA Adverse Event
Injury
Summary report: N
MAINFRAME 8253001 NIM RESPONSE 3.0
MDR report key: 3054959
·
Received April 12, 2013
Report
- Report Number
- 1045254-2013-00327
- Event Type
- Injury
- Date Received
- April 12, 2013
- Date of Event
- February 21, 2013
- Report Date
- March 20, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- ETN
- PMA / PMN Number
- K083124
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. EVALUATION METHOD - NO TESTING METHODS PERFORMED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT AFTER A PROCEDURE THE SURGEON NOTED THE ONE SIDE OF THE PATIENT'S VOCAL CORDS IS "OUT." IT IS UNKNOWN IF THIS WAS A TEMPORARY OR PERMANENT IMPAIRMENT. FOLLOW-UP COMMUNICATION FOUND THE PATIENT HAD A CANCEROUS TUMOR ON THE NERVE. THE PATIENT IS FOLLOWING UP WITH ANOTHER ENT PHYSICIAN FOR A SECOND OPINION. THE NERVE MONITORING DEVICE HAS BEEN USED SEVERAL TIMES SINCE THE REPORTED EVENT WITHOUT ANY PROBLEMS. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159295 | MAINFRAME 8253001 NIM RESPONSE 3.0 | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED, INC. | 8253001 | 205731657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |