BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1920452 · Received December 10, 2010

    Report

    Report Number
    2124215-2010-23803
    Event Type
    Death
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS EVENT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION WAS UNREMARKABLE FOR ANY DEVICE ABNORMALITIES. TELEMETRY OPERATIONS WERE NORMAL AND THE DEVICE PACED AND SENSED APPROPRIATELY WITH A MAGNET RATE OF 100PPM. FORCED LEAD IMPEDANCE MEASUREMENTS WERE PERFORMED AT NOMINAL PARAMETERS WITH 250, 500, 750 AND 1000-OHMS LOADS. BOTH UNIPOLAR AND BIPOLAR LEAD CONFIGURATIONS EXHIBITED NORMAL VALUES. LABORATORY TESTING DID NOT IDENTLFY ANY DEVICE ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE DEATH OF THIS PATIENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT HAD GONE OUT TO GET THE MAIL AND WAS FOUND DEAD. THE CALLER STATED THAT THE PATIENT'S PULSE WAS TAKEN AT THE WRIST, AND NO PULSE WAS FELT. THE CALLER WAS INQUIRING AS TO WHY THE PULSE WOULD BE ABSENT IF THE PACEMAKER WAS STILL FUNCTIONING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4086| S606| 1284| 4087