BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II SR

    MDR report key: 1042885 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33748
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II SR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention THE DEVICE 432-/52349R WAS IMPLANTED 15-FEB-1994| THE DEVICE 430-/74023M WAS IMPLANTED 15-FEB-1994