Brand Name | QUARTET LEAD SMALL-S, 86 CM |
Type of Device | PERMANENT PACEMAKER ELECTRODE |
Manufacturer (Section D) |
ABBOTT |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ABBOTT |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
sonali
arangil
|
15900 valley view court |
sylmar, CA 91342
|
|
MDR Report Key | 13876582 |
MDR Text Key | 288289726 |
Report Number | 2017865-2022-06062 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 05414734510158 |
UDI-Public | 05414734510158 |
Combination Product (y/n) | Y |
Reporter Country Code | SP |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/08/2022 |
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 Model Number | 1456Q/86 |
Device Catalogue Number | 1456Q/86 |
Device Lot Number | A000116433 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/17/2022 |
Initial Date FDA Received | 03/24/2022 |
Supplement Dates Manufacturer Received | 03/25/2022
|
Supplement Dates FDA Received | 04/08/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/08/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | UNIFY ASSURA ICD. |
Patient Outcome(s) |
Required Intervention;
|