BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPOS S PACEMAKER

    MDR report key: 191674 · Received October 15, 1998

    Report

    Report Number
    2182863-1998-00015
    Event Type
    Injury
    Date Received
    October 15, 1998
    Date of Event
    September 2, 1998
    Report Date
    October 15, 1998
    Manufacturer
    ELA MEDICAL, S.A
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THID DEVICE WAS EXPLANTED 191 DAYS AFTER IMPLANT, DUE TO A POCKET INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPOS S PACEMAKER Implant CARDIAC PACEMAKER DXY ELA MEDICAL, S.A 4121 S970311

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R