BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK MINI IV

    MDR report key: 525825 · Received February 20, 2004

    Report

    Report Number
    2124215-2003-05970
    Event Type
    Malfunction
    Date Received
    February 20, 2004
    Date of Event
    August 15, 2003
    Report Date
    August 15, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC. GUIDANT CORP.
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR (ICD) DISPLAYED A 'NOT AVAILABLE' MESSAGE WHEN AN INTERROGATION ATTEMPT WAS MADE. IT WAS ALSO REPORTED THAT AN ERRONEOUS DATE WAS NOTED FOR THE DATE OF THE 'LAST SHOCK DELIVERED.' GUIDANT REC'D THIS DEVICE BACK FOR ANALYSIS IN 2003.

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFO THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A 'NOT AVAILABLE' MESSAGE WHEN AN INTERROGATION ATTEMPT WAS MADE. IT WAS ALSO REPORTED THAT AN ERRONEOUS DATE WAS NOTED FOR THE DATE OF THE 'LAST SHOCK DELIVERED.' GUIDANT RECEIVED THIS DEVICE BACK FOR ANALYSIS IN 12/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK MINI IV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC. GUIDANT CORP. 1790 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other THE DEVICE T135/931928 WAS IMPLANTED 12/11/2003