BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT FAST-CHARGE

    MDR report key: 710402 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-14277
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    March 16, 2006
    Report Date
    March 16, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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) WITH ATRIAL TACHY THERAPIES COULD NOT BE INTERROGATED. IT WAS ALSO REPORTED THAT THE ATRIAL TACHY ELECTROGRAM STORAGE HAD BEEN REPROGRAMMED TO 0% FOLLOWING GUIDANT'S JUNE 17, 2005 PHYSICIAN COMMUNICATION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED TO GUIDANT FOR ANALYSIS.

    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 63 YR Required Intervention