BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP BIPOLAR LEAD

    MDR report key: 120261 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02074
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    April 8, 1997
    Report Date
    June 30, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD SYSTEM WERE EXPLANTED ON APRIL 08, 1997, BECAUSE OF INFECTION AND THE AV ADVISORY LETTER. CPI ANALYSIS IDENTIFIED AN INSULATION DEFECT ON THE BIPOLAR LEAD (MODEL 4269, SERIAL 256899). A NEW SYSTEM WAS IMPLANTED ON APRIL 18, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP BIPOLAR LEAD Implant BIPOLAR LEAD DXY CARDIAC PACEMAKERS 4269 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other THE DEVICE 4269/257059 WAS IMPLANTED 25-OCT-1996| THE DEVICE 0125/214376 WAS IMPLANTED 18-APR-1997| THE DEVICE 0125/205166 WAS IMPLANTED 25-OCT-1996| THE DEVICE 1810/300098 WAS IMPLANTED 25-OCT-1996| THE DEVICE 0125/UNKNOW WAS IMPLANTED| THE DEVICE 4269/UNKNOW WAS IMPLANTED| THE DEVICE 4269/262536 WAS IMPLANTED 18-APR-1997| THE DEVICE 1810/300451 WAS IMPLANTED 18-APR-1997