Brand Name | PENTA 3MM LEAD, 60 CM |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ABBOTT MEDICAL |
6901 preston rd |
plano TX 75024 |
|
MDR Report Key | 12391707 |
MDR Text Key | 268922571 |
Report Number | 1627487-2021-16622 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05414734401913 |
UDI-Public | 05414734401913 |
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,consum |
Type of Report
| Initial,Followup |
Report Date |
09/10/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/31/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/28/2014 |
Device Model Number | 3228 |
Device Catalogue Number | 3228 |
Device Lot Number | 3867355 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/09/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | SCS IPG, MODEL: 3660; SCS IPG, MODEL: 3660 |
Patient Outcome(s) |
Other;
|
Patient Age | 47 YR |
Patient Weight | 113 |
|
|