BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2012-13461

    MDR report key: 2780722 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13461
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A CLINICIAN CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND STATED THE PATIENT HAD BEEN EXPERIENCING SYNCOPE FOR AN UNKNOWN REASON AND HE WAS UNABLE TO INTERROGATE THE DEVICE OR DETERMINE A MAGNET RATE. IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP. TS ADVISED THAT OUR CURRENT MEDICAL RECORDS SHOW THE PATIENT'S PREVIOUS BOSTON SCIENTIFIC DEVICE WAS EXPLANTED OVER TWO YEARS EARLIER AND WE HAVE NO RECORDS INDICATING A NEW DEVICE WAS IMPLANTED. COMPETITOR COMPANIES WERE CONTACTED, HOWEVER THEY ALSO DO NOT HAVE THE PATIENT LISTED AS BEING IMPLANTED WITH ONE OF THEIR DEVICES. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC.

    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 78 YR Life Threatening 1294| 4471| 4470