Brand Name | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR |
Type of Device | DEFIBRILLATION LEAD |
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 |
robert
greenleaf
|
15900 valley view court |
sylmar, CA 91342
|
8184932577
|
|
MDR Report Key | 7724171 |
MDR Text Key | 115155597 |
Report Number | 2017865-2018-10910 |
Device Sequence Number | 1 |
Product Code |
NVY
|
UDI-Device Identifier | 05414734503228 |
UDI-Public | 05414734503228 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P950022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
07/01/2020 |
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 | 06/30/2012 |
Device Model Number | 7121Q/65 |
Device Catalogue Number | 7121Q-65 |
Device Lot Number | 3408575 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/13/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/02/2018 |
Initial Date FDA Received | 07/26/2018 |
Supplement Dates Manufacturer Received | 08/07/2018 06/19/2020
|
Supplement Dates FDA Received | 08/24/2018 07/01/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2011 |
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 | (B)(4) |
Patient Outcome(s) |
Death;
|
Patient Age | 70 YR |