BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 1964297 · Received January 19, 2011

    Report

    Report Number
    2182863-2011-00007
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    SORIN CRM S.A.S.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 SHOWED THAT THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. (B)(4): DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AFTER 9 MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED DUE TO AN INFECTION. THE BIOTRONIK AND ST. JUDE LEADS WERE ALSO REMOVED AND A NEW ELA PARADYM WAS IMPLANTED.

    Description of Event or Problem · 1

    AFTER 9 MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED DUE TO AN INFECTION. THE BIOTRONIK AND ST. JUDE LEADS WERE ALSO REMOVED AND A NEW ELA PARADYM 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 S090303

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R