Brand Name | NEUROPACE RNS SYSTEM |
Type of Device | NEUROPACE RNS SYSTEM |
Manufacturer (Section D) |
NEUROPACE, INC. |
455 n. bernardo ave. |
mountain view CA 94043 |
|
Manufacturer (Section G) |
NEUROPACE, INC. |
455 n. bernardo ave. |
|
mountain view CA 94043 |
|
Manufacturer Contact |
ramona
gonis
|
455 n. bernardo ave. |
mountain view, CA 94043
|
5108822607
|
|
MDR Report Key | 18713511 |
MDR Text Key | 335528829 |
Report Number | 3004426659-2024-00010 |
Device Sequence Number | 1 |
Product Code |
PFN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P100026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/15/2024 |
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? |
No
|
Device Model Number | RNS-320-K |
Device Catalogue Number | 1007927 |
Device Lot Number | 31088-1-1-1 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/15/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 Outcome(s) |
Required Intervention;
Hospitalization;
Other;
|
Patient Age | 57 YR |
Patient Sex | Female |