BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3080881 · Received April 24, 2013

    Report

    Report Number
    3009448963-2013-00050
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    February 24, 2011
    Report Date
    April 1, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODE REMAINS IMPLANTED AND IN SERVICE. 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 DURING A REVIEW OF X-RAYS PERFORMED AT IMPLANT, 90 DAYS AND 180 DAYS POST-IMPLANT, IT WAS DETERMINED THAT THE ELECTRODE HAD MOVED. A REVISION PROCEDURE WAS PERFORMED AND THE ELECTRODE WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176124 S-ICD SYSTEM IMPLANTABLE LEAD-PROD CODE NVY NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1