BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3121943 · Received May 15, 2013

    Report

    Report Number
    3009448963-2013-00058
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PT DEVELOPED A MINOR INFECTION AND THE PT WAS SEEN FOR IRRIGATION OF THEIR XIPHOID INCISION. THE INCISION WAS RE-OPENED IRRIGATED AND CLOSED. THE PT WAS NOTED TO BE OF THIN STATURE AND THE WOUND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215453 S-ICD SYSTEM IMPLANTABLE LEAD - PER CODE NVY NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 1010