BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR ENDOCARDIAL LEAD

    MDR report key: 108818 · Received July 8, 1997

    Report

    Report Number
    2124215-1997-01699
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    March 1, 1997
    Report Date
    April 13, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM EXHIBITED NO PACING SHORTLY AFTER THE IMPLANT. A TEMPORARY WIRE WAS REQUIRED TO SUPPORT THE PATIENT. AN INVASIVE PROCEDURE WAS PERFORMED TO REPOSITION THE BIPOLAR LEAD, MODEL 4261 SERIAL NUMBER 242171 AND THE SYSTEM FUNCTIONED APPROPRIATELY. SHORTLY THEREAFTER, THE SYSTEM AGAIN EXHIBITED NO PACING. ANOTHER INVASIVE WAS PERFORMED TO REPLACE THE IPG. WHEN THE LEAD WAS CONNECTED TO THE NEW IPG THERE WAS STILL NO CAPTURE. THE LEAD WAS REPLACED. A NEW IPG AND LEAD WERE IMPLANTED AND FUNCTION 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 NA Required Intervention THE DEVICE 0444/708378 WAS IMPLANTED 01-MAR-1997| THE DEVICE 4161/016737 WAS IMPLANTED 01-MAR-1997| THE DEVICE 0446/709191 WAS IMPLANTED 27-FEB-1997