BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVA III

    MDR report key: 1954175 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24274
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THERE IS NO FURTHER INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WITH IMPLANTED WITH THIS PACEMAKER FOR OVER FOURTEEN MONTHS WAS ADMITTED TO THE HOSPITAL FOR SYNCOPE DUE TO A SLOW HEART RATE. IT WAS NOTED THE PATIENT WAS LOST TO FOLLOW UP. THE DEVICE COULD NOT BE INTERROGATED. TECHNICAL SERVICES WAS CONTACTED AND DISCUSSED THE APPROPRIATE PROGRAMMER REQUIRED FOR USE WITH THIS MODEL DEVICE. NO MAGNET RESPONSE OR PACING WERE ALSO NOTED. THE PATIENT IS SCHEDULED FOR A PACEMAKER REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA III IMPLANTABLE PULSE GENERATOR NVZ GUIDANT ANGLETON/ST. PAUL 281-07

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L 281-07