FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR ICD, US
MDR report key: 17268086
·
Received July 6, 2023
Report
- Report Number
- 2017865-2023-25141
- Event Type
- Malfunction
- Date Received
- July 6, 2023
- Date of Event
- June 15, 2023
- Report Date
- August 25, 2023
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED EVENT OF MISSING DEFIBRILLATOR THRESHOLD (DFT) EGM WAS NOT CONFIRMED. THE SESSION RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE DFT WAS CARRIED OUT, BUT IT COULD NOT BE DETERMINED IF AN EGM WAS STORED. THE ROOT CAUSE OF THE MISSING EGM COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT RECEIVED A SUCCESSFUL DEFIBRILLATOR THRESHOLD (DFT) TEST, BUT THE HOSPITAL TECHNICIAN WAS UNABLE TO REVIEW THE DFT EGM AFTER THE PROCEDURE. IT WAS NOTED THAT THE DEVICE WAS CLEARED FOLLOWING THE DFT TEST. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419575 | ELLIPSE VR ICD, US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD1377-36QC | A000127661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |