FDA Adverse Event
Death
Summary report: N
QUARTET
MDR report key: 22844386
·
Received August 19, 2025
Report
- Report Number
- 2017865-2025-98060
- Event Type
- Death
- Date Received
- August 19, 2025
- Date of Event
- June 14, 2025
- Report Date
- September 25, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- UDI-DI
- 05414734503198
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN HOSPITAL BETWEEN (B)(6) 2025 - (B)(6) 2025. THE PATIENT WAS SEEN FOR VASCULAR ISSUES IN CLINIC PRIOR TO ADMISSION. THE PATIENT PASSED AWAY (B)(6) 2025. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DUE TO THE DEVICE/SYSTEM. FURTHER INFORMATION WAS REQUESTED FROM THE CLINICIAN BUT WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1483563 | QUARTET | NO MATCH | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1458Q/86 | A000094215 | 05414734503198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| D |