Brand Name | NEUROPACE RNS SYSTEM |
Type of Device | NEUROPACE RNS SYSTEM |
Manufacturer (Section D) |
NEUROPACE, INC. |
455 n. bernardo ave. |
mountain view CA 94043 |
|
MDR Report Key | 10860768 |
MDR Text Key | 216866432 |
Report Number | 3004426659-2020-00056 |
Device Sequence Number | 1 |
Product Code |
PFN
|
UDI-Device Identifier | 00855547005366 |
UDI-Public | 010085554700536617210604 |
Combination Product (y/n) | N |
PMA/PMN Number | P100026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
11/16/2020 |
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 Operator |
No Information
|
Device Model Number | RNS-320-K |
Device Catalogue Number | 1007927 |
Device Lot Number | 30078-1-1-1 |
Initial Date Manufacturer Received |
11/18/2020
|
Initial Date FDA Received | 11/18/2020 |
Supplement Dates Manufacturer Received | 11/18/2020
|
Supplement Dates FDA Received | 11/18/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 44 YR |
|
|