Brand Name | AXONICS |
Type of Device | NEUROSTIMULATOR |
Manufacturer (Section D) |
AXONICS, INC |
26 technology drive |
irvine CA 92618 |
|
Manufacturer Contact |
azucena
eulloqui
|
26 technology drive |
irvine, CA 92618
|
|
MDR Report Key | 16629070 |
MDR Text Key | 312142961 |
Report Number | 3002968685-2023-00040 |
Device Sequence Number | 1 |
Product Code |
EZW
|
UDI-Device Identifier | 10810005340141 |
UDI-Public | 10810005340141 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P180046 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/28/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 05/04/2024 |
Device Model Number | 1201 |
Device Catalogue Number | 1201 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/07/2023
|
Initial Date FDA Received | 03/28/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/04/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 46 YR |
Patient Sex | Female |
|
|