BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD

    MDR report key: 95557 · Received May 8, 1997

    Report

    Report Number
    2124215-1997-01260
    Event Type
    Injury
    Date Received
    May 8, 1997
    Date of Event
    February 14, 1997
    Report Date
    February 13, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 INTERMITTENT LOW LEAD IMPEDANCE PROBLEMS (DURING DEFIBRILLATION TESTING) DURING A ROUTINE DEVICE REPLACEMENT. AFTER EXTENSIVE TESTING AND THREE DIFFERENT PROCEDURES, A NEW TRANSVENOUS DEFIBRILLATION LEAD AND DEVICE WERE IMPLANTED. AFTER DEFIBRILLATION TESTING, AN INTERROGATION OF THE DEVICE (MODEL 1725, SERIAL 253178) IDENTIFIED A FAULT CODE, INDICATING AN OUTPUT PROBLEM. IT'S SUSPECTED THE DEVICE WAS DAMAGED DELIVERING THERAPY INTO THE LOW IMPEDANCE CHRONIC LEAD. A SECOND DEVICE (MODEL 1725, SERIAL 253159) WAS IMPLANTED. THE CHRONIC TRANSVENOUS DEFIBRILLATION LEAD (MODEL 0062, SERIAL 003967) WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD Implant TRANSVENOUS DEFIBRILLATION LEAD LWS CARDIAC PACEMAKERS 0062 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention THE DEVICE 6836/010356 WAS IMPLANTED 05-FEB-1997| THE DEVICE 0063/003173 WAS IMPLANTED 16-SEP-1993| THE DEVICE 6836/006215 WAS IMPLANTED 16-SEP-1993| THE DEVICE 0048/002372 WAS IMPLANTED 05-FEB-1997| THE DEVICE 1725/253159 WAS IMPLANTED 07-FEB-1997| THE DEVICE 0074/005144 WAS IMPLANTED 06-FEB-1997