BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3901939 · Received May 7, 2014

    Report

    Report Number
    3009448963-2014-00061
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN RECEIVED. THE INVESTIGATION IS PENDING ADDITIONAL INFORMATION FROM THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK THE MORNING FOLLOWING THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IMPLANT PROCEDURE. LATERAL X-RAYS WERE TAKEN WHICH SHOWED WHAT APPEARED TO BE AIR AS THE SENSE B ELECTRODE CAUSING A WANDERING BASELINE IN THE S-ECGS WHICH CAUSED THE INAPPROPRIATE THERAPY. THE PATIENT WAS SENT HOME WITH THE DEVICE TURNED OFF. THE DEVICE WAS EVENTUALLY TURNED BACK ON, BUT NO FURTHER PROGRAMMING CHANGES WERE MADE AND NO ADVERSE PATIENT EFFECTS OF ANY FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276781 S-ICD SYSTEM IMPLANTABLE LEAD-PROD CODE NVY NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 1010