BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR

    MDR report key: 710954 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13373
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    January 26, 2006
    Report Date
    January 26, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SHOCKED EXTERNALLY BY EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT HAD CONCERNS AS TO WHY THE DEVICE DIDN'T DELIVER SHOCKS.

    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 64 YR Required Intervention