BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR ENDOCARDIAL LEAD

    MDR report key: 120602 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02415
    Event Type
    Injury
    Date Received
    September 8, 1997
    Date of Event
    July 18, 1997
    Report Date
    July 30, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXHIBITING NO PACING IN THE VENTRICLE. AN INVASIVE PROCEDURE TO ANALYZE THE SYSTEM DETERMINED THAT THE ATRIAL LEAD, MODEL 4261, SERIAL NUMBER 240246 WAS DISLODGED. THE TIP WAS TIGHTENED AND THE LEAD WAS REINSERTED AND THE SYSTEM FUNCTIONED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR ENDOCARDIAL LEAD Implant BIPOLAR LEAD DTB CARDIAC PACEMAKERS 4261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention THE DEVICE 1232/202538 WAS IMPLANTED 18-JUL-1997| THE DEVICE 4271/206517 WAS IMPLANTED 18-JUL-1997