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 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
|
sylmar CA 91342 |
|
MDR Report Key | 15922337 |
MDR Text Key | 304866702 |
Report Number | 2017865-2022-47816 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 05414734503198 |
UDI-Public | 05414734503198 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/05/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/06/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Expiration Date | 04/30/2021 |
Device Model Number | 1458Q/86 |
Device Catalogue Number | 1458Q-86 |
Device Lot Number | A000058319 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/05/2023 |
Date Device Manufactured | 05/23/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 49 YR |
Patient Sex | Female |
|
|