BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 784211 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-18072
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    September 8, 2006
    Report Date
    September 8, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING SURGERY WITH A MAGNET IN PLACE, THE PHYSICIAN NOTED PACING INHIBITION. THIS DEVICE IS PART OF THE AVT LATCHING POPULATION (6/17/2005). ,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE ATRIAL GENERATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention