BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3043597 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02777
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE PATIENT WITH THIS DEVICE SYSTEM WAS REPORTEDLY SYNCOPAL PRIOR TO THE DEVICE IMPLANT PROCEDURE. APPROXIMATELY TEN MONTHS FOLLOWING IMPLANT, THE DEVICE WAS PROGRAMMED VVI 30. APPROXIMATELY THREE MONTHS LATER, THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN DURING PACING. THE PATIENT CONTINUED TO PRESENT WITH SYNCOPE, HOWEVER, THE CAUSE WAS UNKNOWN. THE PATIENT'S PHYSICIAN WAS CONSIDERING EXPLANTING THE DEVICE, AS IT WAS NOT IMPROVING THE PATIENT'S SYMPTOMS. THE LOCAL AREA SALES REPRESENTATIVE DID NOT BELIEVE THAT THE OBSERVATIONS WERE A RESULT OF THE DEVICE SYSTEM. THE PATIENT WAS SCHEDULED TO MEET WITH THEIR CARDIOLOGIST. NO IMMEDIATE PROCEDURES WERE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145193 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening S606| 1882TC| 4136