Brand Name | QUARTET |
Type of Device | PERMANENT PACEMAKER ELECTRODE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
sylmar CA 91342 |
|
MDR Report Key | 10505316 |
MDR Text Key | 206083188 |
Report Number | 2017865-2020-13258 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 05414734503198 |
UDI-Public | 05414734503198 |
Combination Product (y/n) | N |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup,Followup |
Report Date |
11/25/2020 |
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 | 01/31/2021 |
Device Model Number | 1458Q/86 |
Device Catalogue Number | 1458Q-86 |
Device Lot Number | A000052556 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/02/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/20/2020 |
Initial Date FDA Received | 09/08/2020 |
Supplement Dates Manufacturer Received | 11/20/2020 11/25/2020
|
Supplement Dates FDA Received | 11/24/2020 11/26/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 83 YR |
Patient Weight | 91 |
|
|