BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3020590 · Received March 21, 2013

    Report

    Report Number
    3009448963-2013-00028
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION INTO THIS INCIDENT IS CURRENTLY BEING CONDUCTED. ONCE ANY ADDITIONAL INFO DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT DURING A PT FOLLOW UP, THE SKIN AT THE XIPHOID ELECTRODE WOUND SITE WAS NOT SUTURED CLOSED. THE WOUND WAS BANDAGED TO AVOID INFECTION. NO ADVERSE PT EFFECTS WERE REPORTED AND THERE WERE NO REPORTS OF AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118880 S-ICD SYSTEM IMPLANTABLE LEAD LWS CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening