FDA Adverse Event
Malfunction
Summary report: N
AVEIR¿ DELIVERY CATHETER
MDR report key: 23151495
·
Received September 25, 2025
Report
- Report Number
- 2017865-2025-1001338
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Date of Event
- September 8, 2025
- Report Date
- December 9, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- PNJ
- PMA / PMN Number
- P150035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1001337. IT WAS REPORTED THAT A RIGHT ATRIAL (RA) LEADLESS PACEMAKER (LP) PREMATURELY SEPARATED FROM THE DELIVERY CATHETER (DC) WHILE BEING PREPARED FOR TETHER MODE IN THE PATIENT'S BODY. THE LP WAS RETRIEVED AND A REPLACEMENT LP AND DC WERE USED TO COMPLETE THE PROCEDURE. PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2123361 | AVEIR¿ DELIVERY CATHETER | LEADLESS PACEMAKER | PNJ | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LSCD201 | 10976752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Male |