BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 1871174 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-19741
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    October 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE'S LIFE CELL CAPACITY AND CURRENT DRAIN WERE WITHIN NORMAL VARIATION. THE DEVICE IS CURRENTLY UNDERGOING OPERATIONAL AND FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    MICROSCOPIC VISUAL INSPECTION IDENTIFIED A HOLE IN RIGHT ATRIAL (RA NEGATIVE SEAL PLUG AND BODY FLUID CONTAMINATION WAS FOUND IN THE SEAL PLUG CAVITY. ALL OF THE SEAL PLUGS WERE INTACT. ALL OF THE SETSCREWS MOVED FREELY AND OPERATED NORMALLY. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING. THE DEVICE DID NOT EXHIBIT PREMATURE BATTERY DEPLETION AND PERFORMED NORMALLY (OPERATION/FUNCTION) THROUGHOUT LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE'S CHARGE TIME IN (B)(6) 2010 WAS 13.1 SECONDS. IN (B)(6) 2010, THE DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS ASSOCIATED WITH A MONITORING VOLTAGE OF 2.54 VOLTAGE WITH A CHARGE TIME OF 26.9 SECONDS. TECHNICAL SERVICES DISCUSSED MIDDLE-OF-LIFE (MOL) BEHAVIOR. THE PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A155

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R E110| 0184| 4087| A155