BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 1953597 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23945
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE MET SPECIFICATIONS IN TESTING AND ANALYSIS. UPON RECEIPT AT OUR (B)(4) LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. BASED ON RECORDED DATA FROM DEVICE OPERATIONS AND AN ENGINEERING CALCULATION BASED ON PROGRAMMED VALUES, THIS DEVICE MET LONGEVITY EXPECTATIONS. THE DEVICE WAS THEN PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH-VOLTAGE SHOCKING, AND RECORDING FUNCTIONS OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE, WHICH IS INCLUDED IN THE (B)(4), 2007 MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION, IS TO BE RETURNED FOR ANALYSIS. THERE WAS NO EVIDENCE OR ALLEGATION THAT THE DEVICE HAD EXHIBITED THE ADVISORY BEHAVIOR.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER (HCP) THAT THIS DEVICE DISPLAYED A FAULT CODE FOR EXCESSIVE CHARGE TIME WHEN THE PATIENT PRESENTED CLINICALLY AFTER BEING LOST TO FOLLOW-UP FOR MORE THAN A YEAR. HCP ALSO REPORTED THAT DEVICE INTERROGATION SHOWED THE DEVICE HAD DECLARED END OF LIFE (EOL) BATTERY STATUS NINE MONTHS PREVIOUS, THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR (RV) RATE/SENSE CHANNEL IN STORED EPISODES, AND THAT THE PATIENT HAD MORE THAN 1500 DIVERTED SHOCKS. THE NOISE COULD BE PRODUCED CLINICALLY, AND THE RV LEAD'S PACE IMPEDANCE MEASUREMENT WERE LOWER THAN EXPECTED. THE LEAD'S SHOCK IMPEDANCE MEASUREMENT WAS NORMAL. HCP AND A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL AND SCHEDULED FOR DEVICE AND LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED AND REPLACED FOUR DAYS LATER WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A135

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O A135| 4087| 0158