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
|
6502382788
|
|
MDR Report Key | 7807848 |
MDR Text Key | 117955389 |
Report Number | 3004426659-2018-00026 |
Device Sequence Number | 1 |
Product Code |
PFN
|
UDI-Device Identifier | 00855547005267 |
UDI-Public | 010085554700526717190326 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/22/2018 |
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 | 1007694 |
Device Lot Number | 25875-1-1-1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/24/2018 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 35 YR |