BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 1150949 · Received September 5, 2008

    Report

    Report Number
    9610579-2008-00028
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 10, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ELA MEDICAL
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR REPORT COULD NOT BE INTERROGATED DURING A ROUTINE FOLLOW UP. THEREFORE, THE DEVICE WAS EXPLANTED. IT SHOULD BE NOTED THAT THIS DEVICE WAS LISTED IN THE ADVISORY FIELD NOTIFICATION ISSUED IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO MRM - IMPLANTABLE CARDIOVERTER DEFIRBILLATOR MRM ELA MEDICAL 624 S040428

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R