Brand Name | SJM MASTERS SERIES VALVE EXPANDED CUFF |
Type of Device | HEART-VALVE, MECHANICAL |
Manufacturer (Section D) |
ST. JUDE MEDICAL PUERTO RICO, INC. |
p.o. box 998 |
lot 20 b st. |
caguas, puerto rico 00725 |
|
MDR Report Key | 9977148 |
MDR Text Key | 188265457 |
Report Number | 2648612-2020-00037 |
Device Sequence Number | 1 |
Product Code |
LWQ
|
UDI-Device Identifier | 05414734006347 |
UDI-Public | 05414734006347 |
Combination Product (y/n) | N |
PMA/PMN Number | P810002 |
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 |
05/27/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/27/2024 |
Device Model Number | 25MECJ-502 |
Device Catalogue Number | 25MECJ-502 |
Device Lot Number | 6926356 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/12/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/24/2020
|
Initial Date FDA Received | 04/20/2020 |
Supplement Dates Manufacturer Received | 05/20/2020
|
Supplement Dates FDA Received | 05/27/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 29MECJ-502, 18290440.; 29MECJ-502, 18290440. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |
|
|