BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152514 · Received June 17, 2014

    Report

    Report Number
    3009448963-2014-00125
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADD'L ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED, CAPPED, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355278 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L 1010