Brand Name | OCTRODE LEAD KIT, 60CM LENGTH |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ABBOTT MEDICAL |
6901 preston rd |
plano TX 75024 |
|
MDR Report Key | 11136297 |
MDR Text Key | 225721480 |
Report Number | 1627487-2021-00183 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067017246 |
UDI-Public | 05415067017246 |
Combination Product (y/n) | N |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
01/14/2021 |
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 | 05/17/2018 |
Device Model Number | 3186 |
Device Catalogue Number | 3186 |
Device Lot Number | 5508962 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/24/2020 |
Initial Date FDA Received | 01/07/2021 |
Supplement Dates Manufacturer Received | 01/08/2021
|
Supplement Dates FDA Received | 01/14/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | MODEL 3186, SCS LEAD; MODEL 3771, SCS IPG; MODEL 3186, SCS LEAD; MODEL 3771, SCS IPG |
Patient Outcome(s) |
Other;
|
Patient Weight | 82 |
|
|