Brand Name | NALU NEUROSTIMULATION SYSTEM |
Type of Device | SPINAL CORD STIMULATOR |
Manufacturer (Section D) |
NALU MEDICAL INC. |
2320 faraday avenue |
suite 100 |
carlsbad CA 92008 7241 |
|
Manufacturer (Section G) |
NALU MEDICAL INC. |
2320 faraday avenue |
suite 100 |
carlsbad CA 92008 7241 |
|
Manufacturer Contact |
terry
villarba
|
2320 faraday avenue |
suite 100 |
carlsbad, CA 92008-7241
|
7604482360
|
|
MDR Report Key | 11219114 |
MDR Text Key | 228400600 |
Report Number | 3015425075-2021-00003 |
Device Sequence Number | 1 |
Product Code |
GZB
|
UDI-Device Identifier | 00812537033600 |
UDI-Public | 01008125370336001119122717201226 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K183047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/10/2020 |
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 Expiration Date | 12/26/2020 |
Device Model Number | 71005 |
Device Catalogue Number | 71005 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/10/2020
|
Initial Date FDA Received | 01/22/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/27/2019 |
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;
|
Patient Age | 54 YR |