BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3210854 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07421
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    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 RIGHT VENTRICULAR (RV) LEAD AND DEVICE DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS STARTING IN MARCH 2013. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) SENT A SAVE TO DISK IN FOR BOSTON SCIENTIFIC TECHNICAL SERVICES TO ANALYZE. IT WAS NOTED THAT FIVE SHOCK IMPEDANCE VALUES WERE RECORDED AS SATURATED. THE FR INDICATED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310085 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0296| E162| 4470