BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3053228 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05701
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST WAS MADE TO THE FIELD REPRESENTATIVE FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED RIGHT VENTRICULAR (RV) LEAD PRODUCED A RED ALERT IN THE PATIENT'S REMOTE MONITORING SYSTEM DUE TO A HIGH PACING IMPEDANCE MEASUREMENT. THE INFORMATION WAS PROVIDED TO THE FIELD REPRESENTATIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156806 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F163

    Patients

    Seq Age Sex Outcome Treatment
    1