N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7605867
- MDR report key
- 7605867
- Report number
- 1045254-2018-00249
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-18
- Date received
- 2018-06-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- URIZA SHUMS
- Address
- 6743 SOUTHPOINT DR. N. 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 | 0213878681 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-15 | 0 |
Event Narratives#
D
Patient 1
A DISTRIBUTOR REPORTED THAT THE DEVICE HAD A SHORT CIRCUIT DURING THE OPERATION AND THE NERVE COULD NOT BE TESTED DURING THE OPERATION BUT WAS ABLE TO BE USED AFTER THE REPLACEMENT. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.
N
Patient 1
ANALYSIS OF THE RETURNED DEVICE INDICATED THAT VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE GREEN ELECTRODE END TO END OHMS RESISTANCE SHALL BE LESS THAN 2.5 OHMS; THE ACTUAL MEASUREMENTS WAS 1.2 OHMS INDICATING AN IN-SPECIFICATION CONDITION. THE PAIRED ELECTRODE PACKAGES WERE OPENED FOR FURTHER ANALYSIS. THE RESISTANCE BETWEEN PAIRED ELECTRODE CABLES SHALL MEASURE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS WERE; BOTH POLE OF THE RED AND BLUE = 1.8 OHMS, BOTH POLES OF THE ORANGE AND VIOLET = 1.4 OHMS; THERE WERE NO SHORT CIRCUITS; ALL MEASUREMENTS WERE WITHIN TOLERANCE. THERE WAS NO OUT OF SPECIFICATION CONDITION IDENTIFIED AS IT RELATES TO THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.