BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3905370 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11316
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    July 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PRESENTED TO THE HOSPITAL WITH A HEART RATE IN THE 20 BPM TO 30 BPM. IT WAS NOTED THAT TRANSTHORACIC PACING WAS APPLIED AT A RATE OF 50 BPM. THE LOCAL AREA SALES REPRESENTATIVE REPORTED THAT THE PATIENT WAS EVALUATED AND FOUND TO HAVE A BATTERY VOLTAGE OF 2.10V WITH NO PACING AND THE DEVICE REVERTED TO STORAGE MODE. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382265 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R T180| 0185| 4470