BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1851835 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14320
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THE DEVICE WAS FOUND WITH A BATTERY STATUS INDICATOR OF ELECTIVE REPLACEMENT INDICATOR (ERI) AT 2.46 VOLTS. VISUAL INSPECTION IDENTIFIED NO ANOMALIES TO ANY OF THE SEAL PLUGS.THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY AND IS CURRENTLY UNDERGOING LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE, RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE REPLACED DUE TO ELECTROGRAM NOISE AND LOSS OF CAPTURE. THE DEVICE WAS EXPLANTED AND BOTH LEADS WERE SURGICALLY CAPPED. A NEW SYSTEM WAS IMPLANTED IN THE RIGHT PECTORAL REGION. NO DEFIBRILLATION THRESHOLD TESTING WAS PERFORMED DURING THIS PROCEDURE.

    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 89 YR Hospitalization| R 4087| 5076| T165| 0184| E110| 7120