Brand Name | GALLANT HF |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
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 | 16288551 |
MDR Text Key | 308701906 |
Report Number | 2017865-2023-04935 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 05415067032010 |
UDI-Public | 05415067032010 |
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 |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/02/2023 |
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 | 07/31/2024 |
Device Model Number | CDHFA500Q |
Device Catalogue Number | CDHFA500Q |
Device Lot Number | P000151650 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/14/2023 |
Initial Date FDA Received | 02/03/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/30/2022 |
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 | 1457Q/86 QUARTETLEADS; 2088TC/52 TENDRIL STS LEADS; LDA210Q/65 OPTISURE MRI LEADS |
Patient Outcome(s) |
Other;
|
Patient Age | 80 YR |
Patient Sex | Male |