BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 4150882 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17970
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 4, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS REACHED END OF LIFE (EOL). ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATES THE DEVICE CHANGE OUT WAS DELAYED DUE TO INFECTION. FURTHER, ADDITIONAL INFORMATION RECEIVED FROM THE MEDICAL RECORDS INDICATES THE DEVICE WAS EXPLANTED DUE NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633593 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R RV02| T135| MISMATCH