BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2910922 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15506
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE WHEN ATTEMPTING TO IMPLANT THE LEAD TO THE NEW DEVICE IT WAS NOT POSSIBLE TO SECURE THE LEAD AS THE SETSCREW COULD NOT BE SECURED. FINALLY THE LEAD WAS INSERTED INTO THE DEVICE HEADER AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17018 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1