BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 1030958 · Received April 16, 2008

    Report

    Report Number
    9610579-2008-00015
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ELA MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. DURING AN INTERNAL REVIEW PROCESS, THE COMPANY DISCOVERED THAT THIS MDR WAS PREPARED BUT INADVERTENTLY WAS NOT SUBMITTED. THEREFORE, THE MDR IS BEING SUBMITTED AT THIS TIME. THE DEVICE REMAINS IMPLANTED. ANALYSIS OF FOLLOW UP DATA IS PENDING.

    Description of Event or Problem · 1

    DURING THE ROUTINE FOLLOW UP ONE MONTH AFTER IMPLANTATION, THE ICD UNIT INVOLVED IN THIS MDR REPORT COULD NOT BE INTERROGATED. HOWEVER, IT COULD HAVE BEEN COMPLETELY RE-INITIALIZED WITH AN ENGINEERING SOFTWARE; THEREFORE THE DEVICE IS KEPT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO LWS - IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ELA MEDICAL 6550 S071114

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R