Brand Name | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR |
Type of Device | PERMANENT DEFIBRILLATOR ELECTRODES |
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 |
richard
williamson
|
15900 valley view court |
sylmar, CA 91342
|
|
MDR Report Key | 19130854 |
MDR Text Key | 340446290 |
Report Number | 2017865-2024-38974 |
Device Sequence Number | 1 |
Product Code |
NVY
|
UDI-Device Identifier | 05414734502818 |
UDI-Public | (01)05414734502818(10)3849042(17)131031 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | P950022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/23/2024 |
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 | 10/31/2013 |
Device Model Number | 7120Q/58 |
Device Lot Number | 3849042 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/29/2024 |
Initial Date FDA Received | 04/18/2024 |
Supplement Dates Manufacturer Received | 04/17/2024
|
Supplement Dates FDA Received | 04/23/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/29/2012 |
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 | GALLANT DR ICD. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 56 YR |
Patient Sex | Female |
Patient Weight | 80 KG |
Patient Ethnicity | Non Hispanic |
|
|