FDA Adverse Event
Malfunction
Summary report: N
GALLANT HF
MDR report key: 16402332
·
Received February 20, 2023
Report
- Report Number
- 2017865-2023-10358
- Event Type
- Malfunction
- Date Received
- February 20, 2023
- Date of Event
- January 30, 2023
- Report Date
- January 19, 2024
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: UPON REVIEW, THE FOLLOWING VALUES SHOULD BE UPDATED: SECTION D1 BRAND NAME SHOULD BE "GALLANT HF" AND DEVICE PRODUCT CODE SHOULD BE "NIK." SECTION D4 MODEL NUMBER SHOULD BE "CDHFA500Q." LASTLY, SECTION G3 PMA/510K NUMBER SHOULD BE "P030054."
Additional Manufacturer Narrative · 0
FURTHER INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC FOR AN UNRELATED REASON. UPON EXAMINATION, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO HAVE EXHIBITED FAR P-WAVE OVER-SENSING. CORRECTIVE PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1141639 | GALLANT HF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CDHFA500Q | ||
| 1830838 | GALLANT HF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CDHFA500Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |