Brand Name | IPG(INTEGRATED, DUAL 8, 40CM) |
Type of Device | SPINAL CORD STIMULATOR |
Manufacturer (Section D) |
NALU MEDICAL INC. |
2320 faraday avenue |
carlsbad, ca |
|
Manufacturer (Section G) |
NALU MEDICAL |
2320 faraday avenue |
|
carlsbad, ca |
|
Manufacturer Contact |
terry
villarba
|
2320 faraday avenue |
carlsbad, ca
|
4482360
|
|
MDR Report Key | 9857427 |
MDR Text Key | 189310387 |
Report Number | 3015425075-2020-00003 |
Device Sequence Number | 1 |
Product Code |
GZB
|
UDI-Device Identifier | 00812537031071 |
UDI-Public | 01008125370310711119012217200122 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K183047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Modification/Adjustment |
Type of Report
| Initial |
Report Date |
02/20/2020 |
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 |
Health Professional
|
Device Expiration Date | 01/22/2020 |
Device Model Number | 71002 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | 12 MO |
Initial Date Manufacturer Received |
02/20/2020
|
Initial Date FDA Received | 03/19/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/22/2019 |
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) |
Other;
|
Patient Age | 50 YR |
|
|