BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD

    MDR report key: 73831 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00528
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    October 23, 1996
    Report Date
    October 23, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION THIS LEAD (0062-002139) WAS RETURNED TO CPI ON 7/7/1997. LAB ANALYSIS SHOWS: THE LEAD WAS RETURNED SEVERED. ONE SECTION WAS RETURNED, LENGTH= 615. LEAD INSULATION DAMAGED. REMOVED A SUTURE WHICH WAS TIED DIRECTLY TO THE TRILUMEN INSULATION, WITHOUT THE BENEFIT OF A SUTURE SLEEVE 275MM FROM THE TERMINAL PIN. THE TRILUMEN INSULATION IS ABRADED THROUGH TO THE DISTAL HIGH VOLTAGE DBS CABLE 275 MM FROM THE TERMINAL PIN, DUE TO THE SUTURE COUPLED WITH MOVEMENT. DAMAGE CAUSED BY SUTURING DIRECTLY TO THE LEAD.

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING THE ROUTINE REPLACEMENT OF THIS PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)(1600), A SENSING PROBLEM WAS IDENTIFIED WITH A CHRONIC ENDOTAK TRANSVENOUS DEFIBRILLATION LEAD (0062). ATTEMPTS TO LOOSEN THE (0062) LEAD FROM ANOTHER (ICD)(1725) RESULTED IN A BROKEN WRENCH. A FRACTURE WAS IDENTIFIED IN THE (0062) LEAD ABOVE THE POCKET AND BELOW THE RIB CAGE. A COMPLETELY NEW SYSTEM WAS IMPLANTED.

    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 50 YR Other THE DEVICE 0125/212194 WAS IMPLANTED 22-JUL-1996| THE DEVICE 1743/400753 WAS IMPLANTED 22-JUL-1996