Brand Name | CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
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 |
|
Manufacturer Contact |
sonali
arangil
|
15900 valley view court |
sylmar, CA 91342
|
|
MDR Report Key | 15496433 |
MDR Text Key | 300702259 |
Report Number | 2017865-2022-39574 |
Device Sequence Number | 1 |
Product Code |
NVZ
|
UDI-Device Identifier | 05414734505550 |
UDI-Public | 05414734505550 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P910023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
10/17/2022 |
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 | 11/30/2014 |
Device Model Number | CD2257-40Q |
Device Catalogue Number | CD2257-40Q |
Device Lot Number | 4102786 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/13/2022 |
Initial Date FDA Received | 09/28/2022 |
Supplement Dates Manufacturer Received | 10/14/2022
|
Supplement Dates FDA Received | 10/17/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/03/2013 |
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) |
Other;
|
Patient Age | 51 YR |
Patient Sex | Female |
Patient Weight | 91 KG |