BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT AVEIRA DUAL CHAMBER LEADLESS PACEMAKER

    MDR report key: 18151635 · Received November 15, 2023

    Report

    Report Number
    MW5148217
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    November 13, 2023
    Report Date
    November 13, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING IMPLANT OF DUAL LEADLESS PACEMAKER THERE WAS PERFORATION OF THE RIGHT VENTRICLE REQUIRING EMERGENT OPEN CHEST SURGERY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW51487217 ON 12/04/2023 TO UPDATE PROCODE TO PNJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064649 ABBOTT AVEIRA DUAL CHAMBER LEADLESS PACEMAKER LEADLESS PACEMAKER PNJ ABBOTT MEDICAL
    732213 ABBOTT AVEIRA DUAL CHAMBER LEADLESS PACEMAKER LEADLESS PACEMAKER PNJ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Life Threatening