BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 3022744 · Received March 22, 2013

    Report

    Report Number
    9610579-2013-00028
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2013, THE PATIENT PRESENTED ARRHYTHMIA BUT THE IMPLANTED ICD SYSTEM FAILED TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY WITH SHOCKS AT MAXIMUM ENERGY. WHEN THE PATIENT ARRIVED AT THE CLINIC, THE ARRHYTHMIA WAS ON GOING, AND UPON INTERROGATION OF THE ICD, THE DEVICE DISPLAYED THE FOLLOWING WARNING MESSAGE: "SHOCK IMPEDANCE LOW: DEFIBRILLATION SYSTEM INEFFICIENT". ON (B)(6) 2013, A SYNCHRONOUS SHOCK IN THE OPERATING ROOM WAS ATTEMPTED BUT FAILED WITH THE SAME WARNING MESSAGE AND NO SHOCK WAS DELIVERED. THE SYSTEM WAS REPLACED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE ASSOCIATED DEFIBRILLATION LEAD WAS A SORIN ISOLINE 2CR LEAD SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119643 OVATIO MRM SORIN CRM OVATIO VR 6250 S060801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention