BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-15884

    MDR report key: 1864079 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15884
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED AS NECESSASRY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A NON-BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) CONTACTED ONE OF OUR SR ALLEGING HE WAS IN A CHANGEOUT PROCEDURE AND ONE OF OUR BOSTON SCIENTIFIC PACEMAKER HEADERS FELL OFF. THE NON-BOSTON SCIENTIFIC SR WOULDN'T GIVE OUR SR ANY FURTHER INFORMATION EXCEPT THE HOSPITAL LOCATION. OUR SR CONTACTED THAT HOSPITAL CATH LAB AND THEY KNEW NOTHING OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVZ GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1