BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT FAST-CHARGE

    MDR report key: 659511 · Received November 14, 2005

    Report

    Report Number
    2124215-2005-10977
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    August 4, 2005
    Report Date
    August 4, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED. TWO DIFFERENT PROGRAMMERS WERE USED, AND AS THE INTERROGATION STARTS,A TELEMTRY LOST MESSAGE IS DISPLAYED. THE SURFACE ELECTROGRAM DISPLAYS A PACED RYTHYM AT 100-102 BEATS PER MINUTE. THE PATIENT FEELS FINE. THE DEVICE WAS PREVIOUSLY PROGRAMMED TO 0% ATRIAL DATA STORAGE PER THE GUIDANT RECOMMENDATION, AND HAS 6 ATRIAL TACHY EPISODES STORED IN MEMORY. ADDITIONAL INFORMATION WAS RECEIVED STATING THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT FAST-CHARGE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC A155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other