BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 469298 · Received July 1, 2003

    Report

    Report Number
    2182863-2003-00034
    Event Type
    Injury
    Date Received
    July 1, 2003
    Date of Event
    June 6, 2003
    Report Date
    July 1, 2003
    Manufacturer
    ELA MEDICAL, INC.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 7 MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED AND RETURNED BECAUSE THE DEVICE COULD NOT BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL, INC. 614 S020628

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R