BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATIO

    MDR report key: 1013320 · Received March 11, 2008

    Report

    Report Number
    2182863-2008-00013
    Event Type
    Other
    Date Received
    March 11, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPONSE FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP, IT WAS NOTICED THAT AIDA+ HAD NOT BEEN RESET FOR QUITE SOME TIME. A MESSAGE WAS DISPLAYED STATING, "HOLTER TEMPORAL NOT AVAILABLE." WHEN THE AIDA+ WAS RESET, THE INFORMATION WAS DISPLAYED BUT THE FOLLOW-UP INFORMATION WAS LOST. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ELA MEDICAL, S.A.S. 6550 S070122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other