Brand Name | FORTIFY ASSURA VR ICD, US |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
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 | 15210126 |
MDR Text Key | 297700294 |
Report Number | 2017865-2022-17359 |
Device Sequence Number | 1 |
Product Code |
LWS
|
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | P910023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
10/28/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2024 |
Device Model Number | CD1359-40QC |
Device Lot Number | P000140667 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/27/2022 |
Initial Date FDA Received | 08/11/2022 |
Supplement Dates Manufacturer Received | 10/28/2022
|
Supplement Dates FDA Received | 10/28/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/04/2022 |
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 |
Patient Outcome(s) |
Required Intervention;
|