Brand Name | QUARTET |
Type of Device | PERMANENT PACEMAKER ELECTRODE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
sylmar CA 91342 |
|
MDR Report Key | 11141629 |
MDR Text Key | 225832929 |
Report Number | 2017865-2021-00954 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 05414734503334 |
UDI-Public | 05414734503334 |
Combination Product (y/n) | N |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
01/12/2021 |
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 | 10/31/2017 |
Device Model Number | 1458Q/75 |
Device Catalogue Number | 1458Q-75 |
Device Lot Number | 4860140 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/18/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/18/2020 |
Initial Date FDA Received | 01/08/2021 |
Supplement Dates Manufacturer Received | 01/12/2021
|
Supplement Dates FDA Received | 01/13/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|