BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3953793 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-14308
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL ARE FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DEVELOPED AN INFECTION. THE ORIGIN OF THE INFECTION WAS UNKNOWN. DEVICE INTERROGATION FOUND THE DEVICE HAD BEEN AT END OF LIFE (EOL) FOR APPROXIMATELY TWO MONTHS. EOL WAS TRIGGERED BASED ON CHARGE TIME. IT WAS UNKNOWN WHEN A REPLACEMENT PROCEDURE COULD BE SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431931 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening T175| MISMATCH