BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 1031716 · Received April 14, 2008

    Report

    Report Number
    2182863-2008-00021
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    January 31, 2008
    Report Date
    April 14, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES.

    Description of Event or Problem · 1

    AFTER 16+ MOS 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 S060710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R