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 | 5438324 |
MDR Text Key | 38249787 |
Report Number | 3004426659-2016-00001 |
Device Sequence Number | 1 |
Product Code |
PFN
|
UDI-Device Identifier | 00855547005014 |
UDI-Public | 01008555470050141718021100010121190790 |
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 |
02/12/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/16/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Model Number | 1007607 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/27/2016 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/19/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 | 53 YR |