BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1852678 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14379
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    (B)(4). THE DEVICE IS DEPLETING NORMALLY DUE TO THE HIGH ATRIAL OUTPUTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS INDICATING LESS THAN 6 MONTHS OF LONGEVITY REMAINING. AS A RESULT, POSSIBLE PREMATURE BATTERY DEPLETION WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening S603| MISMATCH| (B)(4)| (B)(4)