BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 836007 · Received April 10, 2007

    Report

    Report Number
    9610579-2007-00021
    Event Type
    Injury
    Date Received
    April 10, 2007
    Date of Event
    March 6, 2007
    Report Date
    April 10, 2007
    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. THIS DEVICE WAS MANUFACTURED BETWEEN 04/2003 AND 07/2003 AND WAS LISTED IN THE ADVISORY LETTER ISSUED IN 07/2005. THE DEVICE ANALYSIS IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING PATIENT SCHEDULED FOLLOW UP, 3.5 YEARS AFTER IMPLANTATION, THE DEVICE INVOLVED IN THIS MDR REPORT COULD NOT BE INTERROGATED. THEREFORE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO MRM - IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL 624 8030516

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R