Brand Name | PENTA 3MM LEAD, 60 CM |
Type of Device | SCS PADDLE LEAD |
Manufacturer (Section D) |
ABBOTT MEDICAL |
6901 preston rd |
plano TX 75024 |
|
MDR Report Key | 11725783 |
MDR Text Key | 247468842 |
Report Number | 1627487-2021-13479 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067017253 |
UDI-Public | 05415067017253 |
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 |
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
05/11/2021 |
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 | 09/15/2022 |
Device Model Number | 3228 |
Device Catalogue Number | 3228 |
Device Lot Number | 7663311 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/08/2021 |
Initial Date FDA Received | 04/26/2021 |
Supplement Dates Manufacturer Received | 05/10/2021
|
Supplement Dates FDA Received | 05/11/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Weight | 45 |
|
|