BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2930097 · Received January 25, 2013

    Report

    Report Number
    2124215-2013-01913
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 31, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 DEFIBRILLATION, 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE A NURSING HOME HEALTH CARE PROFESSIONAL (HCP) WAS UNSURE IF THE PATIENT HAD EXPERIENCED A SYNCOPAL EPISODE OR SEIZURE. INTERROGATION OF THE DEVICE REVEALED NO EPISODES THAT CORRELATED WITH THE INCIDENT AND NORMAL DEVICE FUNCTION WAS OBSERVED. ADDITIONALLY, THE PATIENT WAS NOTED TO BE IN CHRONIC ATRIAL FIBRILLATION (AF). THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CRT-D WAS ROUTINELY EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A SYNCOPAL EPISODE AND A SEIZURE. A REMOTE INTERROGATION HAD BEEN COMPLETED AND A HEALTH CARE PROFESSIONAL (HCP) CONTACTED A COMPANY REPRESENTATIVE TO DISCUSS RETRIEVAL OF THE DATA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35691 LIVIAN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening 0157| 4480| 1290| 4542| H220| 4459| 4548