BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 1211706 · Received October 21, 2008

    Report

    Report Number
    2182863-2008-00055
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    July 11, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPONSE FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    AFTER 4+ MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED, BECAUSE OF AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ELA MEDICAL, S.A.S. 6550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R