BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP BIPOLAR LEAD

    MDR report key: 109065 · Received July 8, 1997

    Report

    Report Number
    2124215-1997-01946
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    May 15, 1997
    Report Date
    May 12, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS BIPOLAR LEAD WAS REPOSITONED. TWENTY DAYS AFTER THE IMPLANT THE LEAD WAS FOUND TO BE DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED DUE TO HIGH THRESHOLD MEASUREMENTS, THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED.

    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 60 YR Required Intervention THE DEVICE 0460/271242 WAS IMPLANTED 25-APR-1997