BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 3040817 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01838
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ACCORDING TO OUR RECORDS, THE DEVICE REMAINS IMPLANTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) TWO MONTHS AGO DUE TO A CHARGE TIME GREATER THAN 17.9 SECONDS. THE CALLER WAS INQUIRING AS TO HOW MUCH BATTERY LIFE IS REMAINING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142677 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1857

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 0064| 6017| 1789| 1857| 101-05| 0015