BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1944528 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19489
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RETURN, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST (B)(4) LABORATORY, THE DEVICE MEMORY WAS REVIEWED REVEALING SEVERAL SHORTED LEAD FAULTS HAD OCCURRED PRIOR TO EXPLANT. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS AND THEN TESTED THE PACING, SENSING AND SHOCKING FUNCTIONS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OF PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AN AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS CONCLUDED MULTIPLE SHORTED LEAD FAULTS HAD OCCURRED DURING IMPLANT DUE TO A DAMAGED LEAD AND THAT THIS DEVICE MET SPECIFICATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED; A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED. IN ADDITION, A PORTION OF THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED. MEASUREMENTS POST REPLACEMENT WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED A WARNING SIGNAL. SHOCK IMPEDANCE MEASUREMENT WERE LESS THAN 20 OHMS. A REVIEW OF THE ARRHYTHMIA LOGBOOK REVEALED AN EPISODE HAD OCCURRED APPROXIMATELY TWO MONTHS EARLIER. THE PATIENT WITH THIS DEVICE REMAINS HOSPITALIZED UNTIL A REVISION PROCEDURE CAN BE PERFORMED IN THE NEAR FUTURE. UPON REMOVAL, THIS DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention