BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2910929 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15770
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    February 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER WHO COMMUNICATED THE INFORMATION TO THIS PATIENT'S PHYSICIAN. A DOWNLOAD OF THE DEVICE DATA WILL BE PERFORMED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED ONE MONTH LATER REGARDING THE RESULTS OF A DEVICE MEMORY DOWNLOAD WHICH WAS PERFORMED TO REVIEW THE OUT OF RANGE IMPEDANCE MEASUREMENTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED WITH THE BOSTON SCIENTIFIC REPRESENTATIVE THAT THE DAILY MEASUREMENTS ARE GOOD AND STABLE AND THEREFORE, A LEAD ISSUE IS NOT SUSPECTED AND THERE IS MOST LIKELY JUST AN ISSUE WITH HOW THE COMMAND TEST IS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEFIBRILLATION LEAD WAS EXHIBITING A SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS IN TRIAD CONFIGURATION. THE DAILY MEASUREMENTS WERE STABLE AT 60-62 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18768 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR N164| 4047| 0184| H179| 4517| 4470| 4402