BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO 2

    MDR report key: 734385 · Received July 11, 2006

    Report

    Report Number
    2182863-2006-00037
    Event Type
    Injury
    Date Received
    July 11, 2006
    Date of Event
    June 9, 2006
    Report Date
    July 11, 2006
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS SHOWED THAT THIS DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO THE APPLICABLE STANDARD OPERATING PROCEDURES. DEVICES SOLD AND LABELLED AS STERILE ARE MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. MANUFACTURING DATA FOR THE DEFIBRILLATOR IN OBJECT: MANUFACTURING DATE: 09 MAY 2005. USE BEFORE DATE: 09 JUNE 2006. STERILIZATION LOT NUMBER: S050526. MOREOVER, IT SHOULD BE NOTED THAT EROSION IS A WELL-KNOWN COMPLICATION OF CARDIAC PACING/DEFIBRILLATION SYSTEMS, AND THIS HAS ALREADY BEEN DESCRIBED IN THE LITERATURE.

    Description of Event or Problem · 1

    AFTER 9 MONTHS OF IMPLANTATION, THIS DEVICE WAS EXPLANTED DUE TO EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL, S.A.S. 624 S050526

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R