BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR STEROID ELUTING LEAD

    MDR report key: 143182 · Received November 7, 1997

    Report

    Report Number
    2124215-1997-02869
    Event Type
    Injury
    Date Received
    November 7, 1997
    Date of Event
    September 2, 1997
    Report Date
    September 19, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING AN INVASIVE PROCEDURE TO REPOSITION THE VENTRICULAR LEAD, MODEL 4285 SERIAL NUMBER 202765, THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE THE TIP OF THE WRENCH BROKE OFF AND REMAINED INSIDE THE CONNECTOR BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR STEROID ELUTING LEAD Implant BIPOLAR LEAD DTB CARDIAC PACEMAKERS 4285 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention THE DEVICE 4285/208877 WAS IMPLANTED 01-SEP-1997| THE DEVICE 1230/231462 WAS IMPLANTED 01-SEP-1997| THE DEVICE 1230/227095 WAS IMPLANTED 02-SEP-1997