BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-00788

    MDR report key: 3040646 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00788
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    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 CLINICAL OBSERVATIONS WITH THE CALLER AND STATED THE IMPEDANCE IS STILL WITHIN NORMAL LIMITS BUT THE INCREASE COULD BE A CONCERN. EFFORTS TO OBTAIN ADDITIONAL PRODUCT ISSUE DETAILS WERE UNSUCCESSFUL. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING AN INCREASE IN IMPEDANCE MEASUREMENTS FROM 1100 OHMS TO 1700 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142657 NVY GUIDANT PUERTO RICO BV

    Patients

    Seq Age Sex Outcome Treatment
    1