BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 1880507 · Received October 22, 2010

    Report

    Report Number
    2182863-2010-00101
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    SORIN CRM S.A.S.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER 3 YEARS OF IMPLANTATION, THIS ICD WAS EXPLANTED FOR AN INFECTION. THE BIOTRONIK AND ST. JUDE LEADS WERE ALSO REMOVED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY, DUE TO OTHER HEALTH ISSUES, AND IT MAY HAVE CAUSED THE INFECTION; THE PATIENT MAY NOT GET ANOTHER DEVICE/SYSTEM.

    Description of Event or Problem · 1

    AFTER 3 YEARS OF IMPLANTATION, THIS ICD WAS EXPLANTED FOR AN INFECTION. THE BIOTRONIK AND ST. JUDE LEADS WERE ALSO REMOVED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY, DUE TO OTHER HEALTH ISSUES AND IT MAY HAVE CAUSED THE INFECTION; THE PATIENT MAY NOT GET ANOTHER DEVICE/SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM SORIN CRM S.A.S. 6550 S061109

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R