BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1852611 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14318
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 13, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0906-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD. IT WAS LATER REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. MAGNET APPLICATION WAS NOT ATTEMPTED AS NO MAGNET WAS AVAILABLE. IT WAS THOUGHT THAT THIS DEVICE ENTERED STORAGE MODE BASED ON LENGTH OF IMPLANT. THIS IS A HOSPICE PATIENT AND TO THE REPRESENTATIVE'S KNOWLEDGE NO REVISION PROCEDURE HAS BEEN PLANNED. INFORMATION SUGGESTS THIS DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED RECEIVING THERAPY. HOWEVER, THE DEVICE COULD NOT BE INTERROGATED. THIS DEVICE HAS BEEN IMPLANTED FOR OVER EIGHT YEARS AND THE REPRESENTATIVE HAD THOUGHT LIKELY RELATED TO POSSIBLE END OF LIFE STATUS. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR 4470| 0154| 1861