BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945588 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19913
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 9, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SHOCKING PORTION OF THE CHRONIC DEFIBRILLATION LEAD REMAINS IN SERVICE WITH THE NEW DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RATE/SENSE PORTION OF THIS CHRONIC DEFIBRILLATION LEAD COULD NOT BE FULLY INSERTED INTO THE NEW DEVICE DURING THE CHANGE OUT PROCEDURE. THE PHYSICIAN SUCCESSFULLY TESTED THE RATE/SENSE PORTION OF A NEW BOSTON SCIENTIFIC DEFIBRILLATION LEAD FOR INSERTION INTO THE NEW DEVICE PRIOR TO IMPLANT. HOWEVER, THE NEW DEFIBRILLATION LEAD WAS NOT IMPLANTED. THE HIGH VOLTAGE TERMINAL PINS FROM THE CHRONIC DEFIBRILLATION LEAD WERE INSERTED INTO THE NEW DEVICE WITHOUT COMPLICATION, SO THE PHYSICIAN SURGICALLY ABANDONED THE RATE/SENSE PORTION OF THE CHRONIC DEFIBRILLATION LEAD AND IMPLANTED A NEW PACING LEAD IN THE RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 0185| 4136| 0158| E110| T165| 4086