BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 2911791 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16100
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK IMPEDANCES. THE PATIENT'S PHYSCIAN IS AWARE OF THE SITUATION AND THE SYSTEM REMAINS IMPLANTED AT THE TIME (THE RIGHT VENTRICULAR (RV) LEAD IS A COMPETITOR LEAD) THE PATIENT WILL BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17925 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F160

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening