FDA Adverse Event
Malfunction
Summary report: N
ABBOTT NGQ DEVICE
MDR report key: 18085526
·
Received November 7, 2023
Report
- Report Number
- 2017865-2023-51825
- Event Type
- Malfunction
- Date Received
- November 7, 2023
- Report Date
- November 7, 2023
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE EXHIBITED POST-PACED T-WAVE OVERSENSING. UNKNOWN IF PROGRAMMING CHANGES WERE MADE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1247627 | ABBOTT NGQ DEVICE | No Match | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | NGQ DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |