BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3901960 · Received May 7, 2014

    Report

    Report Number
    3009448963-2014-00056
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FOLLOWING THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), AN EPISODE WAS STORED WHICH SHOWED SMALL QRS AMPLITUDES WITH A BASELINE SHIFT. THE DEVICE OVERSENSED THIS AND STARTED TO CHARGE FOR SHOCK THERAPY, BUT THEN STOPPED. DATE FROM THE DEVICE WAS UPLOADED AND REVIEWED. ENGINEERING DISCUSSED THE LIKELY CAUSE WAS AIR POCKET NEAR THE SENSE ELECTRODE. ENGINEERING NOTED THE SEQUENCE OF EVENTS FOR THIS UNTREATED EPISODE THAT OCCURRED SHORTLY AFTER IMPLANT AND HAS NOT RECURRED SINCE, IS TYPICAL AND SIMILAR TO OTHER CONFIRMED CASES. THE AREA AROUND THE SENSE ELECTRODE WAS PALPITATED DURING FOLLOW-UP APPOINTMENT AND NO NOISE WAS NOTED. NO X-RAYS WERE OBTAINED FOR REVIEW, BUT NO FURTHER ISSUES HAVE BEEN REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276761 S-ICD SYSTEM IMPLANTABLE LEAD-PROD CODE NVY NVY CAMERON HEALTH INC 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 1010