BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2012-15858

    MDR report key: 2910524 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15858
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 13, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS SUSPECTED FRACTURED. THE PATIENT WITH THIS LEAD HAS AN INTRINSIC ATRIAL FIBRILLATION HEART RHYTHM. THE DEVICE WAS PROGRAMMED TO VVIR PACING MODE. NO LEAD REVISION HAS BEEN PERFORMED AS OF THIS DATE AND THIS LEAD WILL BE FURTHER MONITORED. THIS LEAD WAS IMPLANTED IN A SUB-PECTORAL POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18620 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1