FDA Adverse Event
Malfunction
Summary report: N
MAINFRAME 8253002 NIM RESPONSE 3.0 INTL
MDR report key: 3407026
·
Received October 11, 2013
Report
- Report Number
- 1045254-2013-00536
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Date of Event
- September 17, 2013
- Report Date
- September 18, 2013
- Manufacturer
- XOMED MFG JACKSONVILLE
- Product Code
- ETN
- PMA / PMN Number
- K083124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE WAS NOT RETURNED FOR 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 THE ¿NIM FROZE, NO SOUNDS EVEN THOUGH CUSTOMER SAID HE STIMULATED THE NERVE. ELECTRODE PLACEMENT: CHECK, CHANGED PROBE, ELEKTRODES.¿ THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523589 | MAINFRAME 8253002 NIM RESPONSE 3.0 INTL | STIMULATOR, NERVE | ETN | XOMED MFG JACKSONVILLE | 8253002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |