Brand Name | AXONICS |
Type of Device | NEUROSTIMULATOR |
Manufacturer (Section D) |
AXONICS, INC |
26 technology dr |
irvine CA |
|
Manufacturer Contact |
sandra
valencia
|
26 technology dive |
irvine, CA
|
|
MDR Report Key | 16324938 |
MDR Text Key | 309055511 |
Report Number | 3002968685-2023-00022 |
Device Sequence Number | 1 |
Product Code |
EZW
|
UDI-Device Identifier | 10810005340141 |
UDI-Public | 10810005340141 |
Combination Product (y/n) | N |
Reporter Country Code | DE |
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 |
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 Model Number | 1201 |
Device Catalogue Number | 1201 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/11/2023 |
Initial Date FDA Received | 02/08/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | 1101 NEUROSTIMULATOR |
Patient Outcome(s) |
Required Intervention;
|
|
|