N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 8245807
- MDR report key
- 8245807
- Report number
- 1045254-2019-00024
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-12-13
- Date received
- 2019-01-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- URIZA SHUMS
- Address
- 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
- Phone
- 904-904-9043
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NIM? EMG ELECTRODE | ELECTRODE, NEEDLE | MEDTRONIC XOMED INC. | GXZ | 8227411 | 8227411 | 0214752169 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-14 | 0 |
Event Narratives#
D
Patient 1
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT AFTER ALL THE ELECTRODES WERE SET FOR A PAROTIDECTOMY PROCEDURE, THE DOCTOR CONFIRMED THAT ALL ELECTRODES ON THE MONITOR WERE CHECKED. HOWEVER, WHEN THE DOCTOR DID FURTHER TESTING BY PATTING THE PATIENT'S FACE, HE FOUND THAT THERE WAS NO REACTION FROM THE NERVES OF CHIN, THE PURPLE ELECTRODE. THE DOCTOR TRIED TO RESET THE ELECTRODE AND CHECKED ALL THE CONNECTIONS, HOWEVER THERE WAS STILL NO REACTION. FINALLY, THE DOCTOR USED A DIFFERENT PURPLE ELECTRODE TO COMPLETE THE SURGERY. THE SECOND PURPLE ELECTRODE COULD FUNCTION PROPERLY WITH THE SAME MAINFRAME. THERE WAS NO ERROR CODE DISPLAYED ON THE MONITOR. THE HCP NOTED THAT IT WAS THE INITIAL USE OF THE ELECTRODE. THE PROBLEM WAS NOTICED DURING TESTING, THEREFORE THERE WAS NO STIM VALUE SINCE THE DOCTOR HAD NOT USED THE PROBE WHEN THE PROBLEM WAS NOTICED. THE SURGERY WAS DELAYED FOR ABOUT 10 MINUTES. THERE WAS NO PATIENT IMPACT OR INJURY.