BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY VR

    MDR report key: 815442 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-19081
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    October 20, 2006
    Report Date
    October 20, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC, CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS EXPLANTED, AS IT REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) ON SEPTEMBER 25, 2006. THE PHYSICIAN EXPRESSED DISSATISFACTION WITH THE DEVICE LONGEVITY. THE DEVICE WAS IMPLANTED ON JANUARY 10, 2003. A NEW ICD WAS IMPLANTED DURING THIS PROCEDURE WITHOUT COMPLICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A NEW ICD WAS IMPLANTED DURING THE PROCEDURE WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1870 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other