BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3050048 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04275
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK IMPEDANCES. THE PATIENT'S PHYSICAN IS AWARE OF THE SITIUATION AND THE PACING SYSTEM REMAINS IMPLANTED AT THIS TIME. THE PATIENT WILL BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151984 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F163

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening