Brand Name | OPTISURE 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 | 19125742 |
MDR Text Key | 340391219 |
Report Number | 2017865-2024-38928 |
Device Sequence Number | 1 |
Product Code |
NVY
|
UDI-Device Identifier | 05414734507363 |
UDI-Public | (01)05414734507363(10)A000016722(17)170131 |
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 |
Report Date |
04/17/2024 |
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 | 01/31/2017 |
Device Model Number | LDA220Q/65 |
Device Lot Number | A000016722 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/28/2024
|
Initial Date FDA Received | 04/17/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/17/2016 |
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 | 1458Q/92.; 2088TC/52.; CDHFA500Q. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
Patient Sex | Female |
Patient Weight | 82 KG |