Brand Name | ISOFLEX OPTIM LEAD |
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 | 17706093 |
MDR Text Key | 322922820 |
Report Number | 2017865-2023-42504 |
Device Sequence Number | 1 |
Product Code |
NVY
|
UDI-Device Identifier | 05414734502351 |
UDI-Public | 05414734502351 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | P960030 |
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 |
09/08/2023 |
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 | 1948/58 |
Device Lot Number | 4429927 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/17/2023
|
Initial Date FDA Received | 09/07/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/20/2014 |
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 | ASSURITY MRI; TENDRIL |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |