Brand Name | FORTIFY ASSURA VR ICD, 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 |
elizabeth
boltz
|
15900 valley view court |
sylmar, CA 91342
|
|
MDR Report Key | 9533383 |
MDR Text Key | 173165560 |
Report Number | 2017865-2019-18677 |
Device Sequence Number | 1 |
Product Code |
LWS
|
UDI-Device Identifier | 05414734507974 |
UDI-Public | 05414734507974 |
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 |
company representative,user f |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
03/20/2020 |
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 | 10/31/2016 |
Device Model Number | CD1357-40Q |
Device Catalogue Number | CD1357-40Q |
Device Lot Number | 4846577 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/17/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/11/2019 |
Initial Date FDA Received | 12/30/2019 |
Supplement Dates Manufacturer Received | 03/12/2020
|
Supplement Dates FDA Received | 03/20/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/22/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-0003-2018;Z-0115-2017 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 59 YR |