FDA Adverse Event
Malfunction
Summary report: N
GALLANT HF
MDR report key: 19244424
·
Received May 3, 2024
Report
- Report Number
- 2017865-2024-40472
- Event Type
- Malfunction
- Date Received
- May 3, 2024
- Date of Event
- April 16, 2024
- Report Date
- May 10, 2024
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- UDI-DI
- 05415067032010
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVER-SENSING. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES. QTD MRI.
Description of Event or Problem · 0
NEW INFORMATION RECEIVED NOTES THAT PROGRAMMER CHANGES WERE MADE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758582 | GALLANT HF | NO MATCH | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CDHFA500Q | A000151710 | 05415067032010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | DURATA MRI| QUARTET| TENDRIL |