FDA Adverse Event
Malfunction
Summary report: N
AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
MDR report key: 15179600
·
Received August 5, 2022
Report
- Report Number
- 2017865-2022-16933
- Event Type
- Malfunction
- Date Received
- August 5, 2022
- Date of Event
- July 18, 2022
- Report Date
- August 11, 2022
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- PNJ
- UDI-DI
- 05415067034472
- PMA / PMN Number
- P150035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: D2 PRODUCT CODE UPDATED TO PNJ.
Description of Event or Problem · 0
IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED FOR AN INITIAL IMPLANT PROCEDURE. DURING MULTIPLE POSITIONING ATTEMPTS, THE VENTRICULAR LEADLESS PACEMAKER WAS SEEN TO HAVE HIGH PACING IMPEDANCE, FAILURE TO CAPTURE, AND UNDER SENSING. IT WAS NOTED THAT THE PEACEMAKER MAY HAVE BEEN POSITIONED IN TISSUE AFFECTED BY ACUTE MYOCARDIAL INFARCTION. THE DELIVERY CATHETER WAS EXCHANGED AND THE DEVICE WAS IMPLANTED AT A DIFFERENT LOCATION. THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930681 | AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE | LEADLESS PACEMAKER | PNJ | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LSP112V | S000086359 | 05415067034472 |
| 1950387 | AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE | LEADLESS PACEMAKER | PNJ | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LSP112V | S000086359 | 05415067034472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | AVEIR¿ DELIVERY CATHETER LSCD111 |