BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-05488

    MDR report key: 3052804 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05488
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    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 AN UNKNOWN RIGHT ATRIAL LEAD WAS SUSPECTED TO HAVE DISLODGED DUE TO AN TIMING ANOMALY NOTED ON AN ELECTROCARDIOGRAM. NO ADDITIONAL INFORMATION COULD BE OBTAINED ABOUT THE EVENT, RESOLUTION, OR LEAD INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156546 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4285| 0465| 0950| 030-247| 1283