BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2781146 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13305
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 1, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    -

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A HEART ATTACK AND ALLEGED THAT THE DEVICE IS NOT WORKING AS INTENDED AND NEEDED A DEVICE CHANGE OUT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED ON HOW TO PROCEDURE FOLLOWING THE PATIENTS RECENT HEART ATTACK. THE AGENT ADVISED PATIENT ON HOW TO CONTACT A FACILITY AND ALSO DISCUSSED THAT THIS DEVICE DOES NOT TREAT FOR HEART ATTACKS IT WILL ONLY TREAT FAST ARRHYTHMIA'S. AT THIS TIME THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1