BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3040776 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01123
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 17, 2014
    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

    .

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE ICD, TOGETHER WITH THE RIGHT VENTRICULAR (RV) LEAD, CONTINUED TO EXHIBIT HIGH SHOCK IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED A RED ALERT TO BE DECLARED DUR TO HIGH SHOCK LEAD IMPEDANCES. ( THE RIGHT VENTRICULAR DEFIBRILLATION LEAD MODEL AND SERIAL NUMBER IS UNKNOWN). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144124 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F162

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening