BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2920861 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01182
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    October 31, 2012
    Report Date
    March 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE DUE TO EXTENDED CHARGE TIMES. THIS PRODUCT WAS EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED EXTENDED CHARGE TIMES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN PLANNED TO CONTINUE TO MONITOR. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT RECEIVED A SHOCK AND HAD PASSED OUT DUE TO MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) ASSOCIATED WITH AN EXTENDED CHARGE TIME. THE PHYSICIAN HAS DECIDED TO HOLD OFF ON A CHANGEOUT PROCEDURE AT THIS TIME DUE TO OTHER HEALTH ISSUES THAT THE PATIENT HAS BEEN DEALING WITH. THE PATIENT WAS STARTED ON AMIODARONE AND PROGRAMMING ADJUSTMENTS WERE MADE TO RATE SMOOTHING FEATURE. NO ADDITIONAL OBSERVATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26645 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening T180| 0185