BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2060007 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06534
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE DEVICE EXCEEDED THE LABELING LONGEVITY. IN REGARD TO THE CLINICAL OBSERVATION, THE DEVICE MEMORY CONFIRMED NINETEEN MANUAL CAPACITOR REFORMATIONS OCCURRED WITHIN AN EIGHT MINUTE SPAN BEFORE THE PATIENT WAS SCHEDULED FOR THE REPLACEMENT PROCEDURE. THIS CAUSED THE BATTERY STATUS TO CHANGE FROM MOL2 TO ERI DUE TO CHARGE TIME. IN CONCLUSION, THE DEVICE PERFORMED AS DESIGNED AND ERI WAS DECLARED DUE TO THE MULTIPLE MANUAL CAPACITOR REFORMATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A MANUAL CAPACITOR REFORMATION. THE MONITORING VOLTAGE WAS 2.57 VOLTS WITH A CHARGE TIME MEASUREMENT OF 18.9 SECONDS. THE PATIENT WAS SCHEDULED FOR A DEVICE REPLACEMENT PROCEDURE THIRTEEN DAYS LATER. THE DEVICE WAS ROUTINELY INTERROGATED BEFORE THE REPLACEMENT PROCEDURE AND WAS FOUND TO HAVE A BATTERY STATUS OF MIDDLE OF LIFE 2 (MOL2) WITH THE MONITORING VOLTAGE AT 2.57 VOLTS AND A CHARGE TIME MEASUREMENT OF 16.1 SECONDS. TECHNICAL SERVICES (TS) DISCUSSED THAT THE MANUAL CAPACITOR REFORMATION MAY EXPLAIN THE DEVICE BEHAVIOR. THE DEVICE WAS EXPLANTED WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

    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 62 YR Required Intervention T165| 0154| 4054| MISMATCH| 1861