BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1852725 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14761
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    May 28, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THAT THIS ICD AND NEW NON-BOSTON SCIENTIFIC LEAD REMAIN IN-SERVICE. 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) WAS SEEN IN THE EMERGENCY ROOM COMPLAINING OF BEING DIZZY AND HAVING A LOW HEART RATE. INTERROGATION REVEALED AN INTERMITTENT LOSS OF CAPTURE. THE PATIENT'S THRESHOLDS HAD DROPPED AND A 40 OHM DROP IN IMPEDANCES WAS ALSO NOTED. THE PATIENT DID HAVE A HIGH POTASSIUM AS WELL. THE PHYSICIAN AT THE TIME THOUGHT THAT ONCE THE PATIENT'S POTASSIUM RETURNED TO NORMAL THE THRESHOLDS WOULD ALSO IMPROVE AND THE OUTPUTS WERE RAISED. THE PHYSICIAN ADVISED THE PATIENT TO FOLLOW-UP IN TWO WEEKS. THE PATIENT DID NOT MEET THAT APPOINTMENT. THE PATIENT WAS RECENTLY SEEN, OVER A MONTH AND A HALF LATER, AND THE DEVICE WAS PROGRAMMED TO MAX OUTPUTS. THE IMPEDANCES HAS REMAINED STABLE. AS A RESULT THE PHYSICIAN ELECTED TO DO A LEAD REVISION. THE REPRESENTATIVE CONFIRMED THERE WAS NO COIL TO COIL CONTACT. THE OLD DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. A NEW, NON-BOSTON SCIENTIFIC LEAD WAS IMPLANTED BASICALLY IN THE SAME SPOT AS THE OLD DEFIBRILLATION LEAD. THE POCKET WAS CLOSED AND THE DEVICE AGAIN DETECTED A LOSS OF CAPTURE WITH THIS NEW LEAD. AS A RESULT, THE POCKET WAS REOPENED AND THE NEW LEAD WAS PLACED HIGHER IN THE SEPTUM WITH NORMAL THRESHOLDS AND IMPEDANCES. THERE WAS THOUGHT THAT DUE TO THE PATIENT'S PREVIOUS MYOCARDIAL INFARCTION, THE DEAD TISSUE WAS MORE LIKELY RELATED TO THE ISSUES PRESENT. THE REPRESENTATIVE NOTED THAT THERE APPEARED TO BE NOTHING WRONG WITH THE INITIAL DEFIBRILLATION LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4086| A135| 0157| T165