Brand Name | GALLANT HF |
Type of Device | NO MATCH |
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 | 17283649 |
MDR Text Key | 318675924 |
Report Number | 2017865-2023-25336 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/13/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2024 |
Device Model Number | CDHFA500Q |
Device Catalogue Number | CDHFA500Q |
Device Lot Number | S000086804 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/20/2023
|
Initial Date FDA Received | 07/07/2023 |
Supplement Dates Manufacturer Received | 09/13/2023
|
Supplement Dates FDA Received | 09/13/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/23/2022 |
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 | OPTISURE MRI; QUARTET; TENDRIL |
Patient Age | 67 YR |
Patient Sex | Male |
|
|