BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATIO

    MDR report key: 1242517 · Received November 21, 2008

    Report

    Report Number
    2182863-2008-00062
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, THE STORED PATIENT FILE SHOWED A WARNING. THE DEVICE REMAINS IMPLANTED. A RESPONSE FROM THE MFR IS PENDING.

    Description of Event or Problem · 1

    THE WARNING "ATRIAL SHOCK LEAD CONTINUITY: OPEN" WAS DISPLAYED WHEN A STORED PT FILE WAS REVIEWED FROM A FOLLOW-UP 3 DAYS PRIOR. THE SALES REP REPORTED THAT THE PRINTED REPORT FROM THE DAY OF THE FOLLOW-UP WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM ELA MEDICAL, S.A.S. 6550 S070521

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other