BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 6237826 · Received January 10, 2017

    Report

    Report Number
    2124215-2016-17534
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    October 12, 2016
    Report Date
    October 13, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040/S235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BROUGHT INTO THE CLINIC FOR AN IN OFFICE IMPEDANCE CHECK. THE ROOT CAUSE OF THE REPORTED CLINICAL OBSERVATIONS WAS NOT IDENTIFIED. 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 SYSTEM EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF 125 OHMS. A REVIEW OF THE DATA SHOWED THE MEASUREMENTS HAVE BEEN BETWEEN 100-125 OHMS OVER THE PAST THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22547 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 0292| 4135| E162