BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 711232 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13105
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    January 9, 2006
    Report Date
    January 9, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PREMATURELY DEPLETED IN THE BOX, PRIOR TO USE. THE DEVICCE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other