BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 670385 · Received February 1, 2006

    Report

    Report Number
    2182863-2006-00007
    Event Type
    Injury
    Date Received
    February 1, 2006
    Date of Event
    January 11, 2006
    Report Date
    February 1, 2006
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEBRUARY 1, 2006: THE ANALYSIS FROM THE MANUFACTURER IS PENDING. MARCH 20, 2006: PLEASE SEE THE ATTACHED ANALYSIS #060201 FOR COMPLETE DETAILS. UPON RECEPTION, THE DEVICE WAS INTERROGATED: THE ELECTIVE REPLACEMENT INDICATOR WAS REACHED; THE WARNING RELATED TO LONG CHARGE TIMES WAS DISPLAYED; ACCORDING TO THE SHOCK STATISTIC COUNTERS, NO SHOCK THERAPY WAS DELIVERED OVER THE LAST MONTHS, WHICH CONFIRMS THE LONG CHARGE TIMES WERE NOT RELATED TO ARRHYTHMIA, BUT TO AUTOMATIC REFORMING AND MANUAL TESTING; PREVIOUS FOLLOW-UP ON 12/01/2006 AT 00:03. CURRENT FOLLOW-UP 02/02/2006 AT 18:01. WARNINGS: MAGNET RATE (MIN-'): 80 ERI. CHARGINGS ABORTED (>40 S): 4 - WARNINGS. SOME CHARGE TESTS WER PERFORMED, WHICH ALL FAILED EXCEPT ONE OF THEM: THE CHARGE TEST AT LOW ENERGY (5J) WAS COMPLETED WITH A CHARGE TIME OF 4.8 S. IN DEPTH INVESTIGATION REVEALED FAILURE OF ONE OF THE SHOCK CAPACITORS. CONCLUSION: THE DEVICE INVOLVED IN THIS CASE WAS EXPLANTED 45 MONTHS AFTER IMPLANTATION BECAUSE OF LONG TIME CHARGING; ITS ANALYSIS REVEALED FAILURE OF ONE OF THE SHOCK CAPACITORS. THE DEVICE IS RETAINED IN THE RETURNED PRODUCT STORAGE AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP INTERROGATION A MESSAGE OCCURRED STATING, "CHARGINGS ABORTED (>40 S):4-WARNINGS". THEREFORE, THE DEVICE WAS EXPLANTED IN 2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP INTERROGATION A MESSAGE OCCURRED STATING, "CHARGINGS ABORTED (>40 S) :4-WARNINGS." THEREFORE, THE DEVICE WAS EXPLANTED ON JANUARY 11, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL, S.A.S. 614 M020314

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R