BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 816051 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-19482
    Event Type
    Injury
    Date Received
    February 8, 2007
    Date of Event
    November 7, 2006
    Report Date
    November 7, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AT A POST-IMPLANT CHECK, THIS PACING SYSTEM WAS NOTED TO BE FUNCTIONING NORMALLY WITH UNCHANGED MEASUREMENTS FROM THE IMPLANT PROCEDURE. THE PATIENT RECENTLY BECAME ILL WITH PNEUMONIA. SINCE BECOMING ILL, THE ATRIAL AND RIGHT VENTRICULAR LEADS BOTH EXHIBITED NON-CAPTURE. IMPEDANCES AND SENSING DATA WERE NOTED AS NORMAL AND UNCHANGED. A REVIEW OF X-RAYS REFUTED SUSPECTED DISLODGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4088 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention