BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2153350 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06443
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    November 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DIED IN (B)(6) 2011. THE PATIENT'S MEDICAL RECORDS WAS REVIEWED BY THE LOCAL REPRESENTATIVE. AN ECHOCARDIOGRAM WAS DONE IN (B)(6) 2011 AND NO VEGETATION WAS IDENTIFIED. IT WAS SUSPECTED THAT THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST. ON THE DATE OF THE ADVERSE EVENT, THE PARAMEDICS WERE CALLED TO THE RESIDENCE AND THE PATIENT WAS FOUND IN PULSELESS ELECTRICAL ACTIVITY (PEA). THE PARAMEDICS REPORTED THAT THE EPSIODE OF PEA CHANGED TO VENTRICULAR FIBRILLATION (VF). THE ARRHYTHMIA WAS SENSED AND THE PATIENT WAS SHOCKED TWICE BY THE DEVICE. THE ARRHYTHMIA WAS NOT SUCCESSFULLY TERMINATED. AT SOME POINT, THE RHYTHM SPONTANEOUSLY STABILIZED BUT THEN DETERIORATED BACK INTO VF. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR TRIPLE VESSEL CORONARY ARTERY DISEASE. THE PATIENT HAD REFUSED SURGERY AND WAS ON DIALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THE PLANS FOR INTERVENTION HAD NOT YET BEEN COMMUNICATED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ADMITTED TO THE HOSPITAL DUE TO A POSSIBLE INFECTION FROM VEGETATION NOTED ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THERE WAS NO EVIDENCE THAT ANY INTERVENTION HAS TAKEN PLACE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L 0157| T135