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 |
|
MDR Report Key | 10216164 |
MDR Text Key | 197081729 |
Report Number | 2017865-2020-08439 |
Device Sequence Number | 1 |
Product Code |
NVY
|
UDI-Device Identifier | 05414734502818 |
UDI-Public | 05414734502818 |
Combination Product (y/n) | N |
PMA/PMN Number | P950022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial,Followup |
Report Date |
08/18/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/30/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2020 |
Device Model Number | 7120Q/58 |
Device Catalogue Number | 7120Q-58 |
Device Lot Number | A000043701 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/30/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/29/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 64 YR |
|
|