BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2051709 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04275
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 AND/OPR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (DEVICE BATTERY HAS REACHED END OF LIFE (EOL) IN (B)(6) 2011. THE LOCAL REPRESENTATIVE WAS CONTACTED AND INFORMED OF THE ALERT. THE INFORMATION FROM THE DATA UPLOAD WAS REVIEWED BY THE CLINIC. BOSTON SCIENTIFIC RECEIVED INFORMATION THE NEXT DAY THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT HAD DIED. TECHNICAL SERVICES WAS INFORMED THAT THIS DEVICE HAD TRIGGERED END-OF-LIFE (EOL) INDICATORS DUE TO A CHARGE TIME OF 31 SECONDS ASSOCIATED WITH A MONITORING VOLTAGE OF 2.69 VOLTS. IN (B)(6) 2011, THE RECORDED CHARGE TIME WAS IN THE 23-24 SECOND RANGE. THE PATIENT HAD ARRIVED AT THE CLINIC TO SCHEDULE A DEVICE REPLACEMENT PROCEDURE AND UNDERGO A STRESS TEST. DURING THE STRESS TEST, SPONTANEOUS VENTRICULAR FIBRILLATION (VF) DEVELOPED. THE DEVICE SENSED THE ARRHYTHMIA AND MULTIPLE SHOCK THERAPIES WERE DELIVERED. ADDITIONALLY, MULTIPLE EXTERNAL DEFIBRILLATIONS WERE ATTEMPTED. DESPITE THESE EFFORTS, TERMINATION OF THE VF WAS UNSUCCESSFUL AND THE PATIENT DIED. THERE WERE NO REPORTED ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION OF FUNCTIONALITY. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE DEVICE WAS NOT EXPLANTED FOLLOWING THE DEATH OF THIS PATIENT. THE FUNCTIONING OF THE DEVICE WAS NORMAL AND THERE WERE NO COMPLAINTS CONCERNING THIS DEVICE'S OPERATION OR FUNCTIONALITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0158| T180