BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 776264 · Received November 2, 2006

    Report

    Report Number
    9610579-2006-00057
    Event Type
    Injury
    Date Received
    November 2, 2006
    Date of Event
    September 26, 2006
    Report Date
    November 2, 2006
    Manufacturer
    ELA MEDICAL
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 08/2003 - 08/2004 AND WAS LISTED IN THE ADVISORY LETTER ISSUED IN 07/05. THE DEVICE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT WAS EXPLANTED PROPHYLACTICALLY 30 MONTHS AFTER IMPLANT BECAUSE IT WAS LISTED IN THE ADVISORY LETTER ISSUED IN JULY 2005. MOREOVER, THE PHYSICIAN REPORTED THE ABSENCE OF BGM IN EPISODES STORED IN 2005 (THESE BGMS CORRESPOND TO STORED DATA WHEN AN ARRHYTHMIA EPISODE IS SENSED BY THE DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO MRM - IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL 624 5040127

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R