BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DOWN-SIZED PLUS

    MDR report key: 120291 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02104
    Event Type
    Injury
    Date Received
    September 8, 1997
    Date of Event
    May 26, 1997
    Report Date
    June 5, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A TRANSVENOUS DEFIBRILLATION LEAD EXPERIENCED EXIT BLOCK AND HIGH LEAD IMPEDANCE. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REPLACE THE ICD. ALSO NOTED AN INSULATION DEFECT WAS IDENTIFIED, AND REPAIRED ON THE MODEL 0125, SERIAL 213261 LEAD. THE ICD IS A VENTAK AV, IS NOT MARKET RELEASED IN THE UNITED STATES, AND IS INVOLVED IN A PRODUCT ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DOWN-SIZED PLUS Implant TRANSVENOUS DEFIBRILLATION LEAD LWS CARDIAC PACEMAKERS 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention THE DEVICE 1810/300033 WAS IMPLANTED 02-SEP-1996| THE DEVICE 4269/255241 WAS IMPLANTED 02-SEP-1996| THE DEVICE 1810/300723 WAS IMPLANTED 26-MAY-1997