BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 2091763 · Received May 17, 2011

    Report

    Report Number
    2182863-2011-00037
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 19, 2011
    Manufacturer
    SORIN CRM S.A.S.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4), 2011. SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS WERE MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THIS ICD WAS EXPLANTED BECAUSE OF AN INFECTION.

    Description of Event or Problem · 1

    THIS ICD WAS EXPLANTED BECAUSE OF AN INFECTION. A NEW PARADIGM ICD 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 S100105

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R