BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTO

    MDR report key: 508202 · Received January 8, 2004

    Report

    Report Number
    2182863-2004-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2004
    Date of Event
    April 7, 2003
    Report Date
    January 8, 2004
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS STILL IN THE STERILE PACKAGE WHEN IT WAS INTERROGATED PRIOR TO A CASE AND IT WAS FOUND THAT THE DEVICE WAS AT EOL. BECAUSE THERE WAS NO PT INVOLVEMENT, A DEVICE DEFECT REPORT WAS FILED ON THIS ICD ON AUGUST 19, 2003. HOWEVER, IN DECEMBER 2003, DURING AN FDA AUDIT, THE INVESTIGATOR INFORMED CO THAT THIS DEVICE SHOULD HAVE BEEN REPORTED AS AN MDR BECAUSE IT WAS A FAILURE SIMILAR TO OTHER MDR REPORTABLE FAILURES. THEREFORE, AS A RESULT OF AN FDA OBSERVATION, CO IS FILING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL, S.A. 614 S020409

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other