BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1951586 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23364
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 26, 2010
    Report Date
    February 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    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.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE DEVICE HAD BEEN ELECTIVELY EXPLANTED/ REPLACED IN (B)(6) 2013. THE COMPETITOR RIGHT ATRIAL (RA) AND COMPETITOR RIGHT VENTRICULAR (RV) LEADS WERE EXTRACTED AND REPLACED. BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE SYSTEM WAS EXPLANTED WITHOUT INCIDENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (HIGH RIGHT VENTRICULAR (RV) PACING IMPEDANCE. THE LOCAL REPRESENTATIVE WAS NOTIFIED AND THE LATITUDE DATA UPLOAD WAS REVIEWED BY THE CLINIC NURSE. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO DISCUSS THE RED ALERT. TECHNICAL SERVICES REPORTED THAT THE DEVICE'S RV PACING IMPEDANCE ALERT HAD BEEN PROGRAMMED TO 1000 OHMS AND WAS ATTACHED TO A COMPETITOR RV DEFIBRILLATION LEAD. TECHNICAL SERVICES COMMENTED THAT THIS MAY EXPLAIN THE ALERT FOR GREATER THAN 1400 OHMS. THE RV IMPEDANCE HAD BEEN STABLE IN THE 500-600 OHM RANGE AND THE SUDDEN INCREASE MAY REPRESENT A PRIMARY LEAD ISSUE. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE PHYSICIAN IS DISCUSSING OPTIONS WITH THE PATIENT AND NO INVASIVE INTERVENTION HAS BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4076| 6949| T165