BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATIO

    MDR report key: 797458 · Received November 28, 2006

    Report

    Report Number
    2182863-2006-00086
    Event Type
    Other
    Date Received
    November 28, 2006
    Date of Event
    September 21, 2006
    Report Date
    November 28, 2006
    Manufacturer
    ELA MEDICAL, S. A.S.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED BECAUSE A HIGHER OUTPUT DEVICE WAS NEEDED. THE ANALYSIS FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE WAS NOT IMPLANTED BECAUSE THE PATIENT NEEDED A HIGHER OUTPUT DEVICE; COULD NOT GET AN ADEQUATE SAFETY MARGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ELA MEDICAL, S. A.S. 6550 S060626

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other