BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2013544 · Received March 10, 2011

    Report

    Report Number
    2182863-2011-00018
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 11, 2011
    Manufacturer
    SORIN CRM S.A.S.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4), 2011THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE, THE DEVICE DID NOT CONVERT THE PATIENT AT 34 JOULES. THE DEVICE WAS NOT IMPLANTED; A NEW SORIN PARADYM WAS IMPLANTED.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE, THE DEVICE DID NOT CONVERT THE PATIENT AT 34 JOULES. THE DEVICE WAS NOT IMPLANTED; A NEW SORIN PARADIGM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM SORIN CRM S.A.S. 6550

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR