Brand Name | ALGOVITA SPINAL CORD STIMULATION |
Type of Device | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) |
Manufacturer (Section D) |
NUVECTRA CORPORATION |
10675 naples street ne |
blaine 55449 |
|
Manufacturer (Section G) |
NUVECTRA CORPORATION |
10675 naples street ne |
|
blaine MN 55449 |
|
Manufacturer Contact |
david
douglas
|
10675 naples street ne |
blaine, MN 55449
|
7634047531
|
|
MDR Report Key | 8196740 |
MDR Text Key | 131419606 |
Report Number | 3010309840-2018-00139 |
Device Sequence Number | 1 |
Product Code |
LGW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P130028 |
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 |
12/26/2018 |
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 | 06/25/2020 |
Device Model Number | 1124-60T |
Device Catalogue Number | 1124-60T |
Device Lot Number | W4387321 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/11/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/27/2018
|
Initial Date FDA Received | 12/26/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/25/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 38 YR |