BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2913230 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00384
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    June 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD THAT CREATED A STORED EPISODE IN THE DEVICE AND CAUSED THE DEVICE TO CHARGE (BUT WAS DIVERTED). ALSO NOTED WERE EPISODES OF PACEMAKER MEDIATED TACHYCARDIA (PMT). THE FIELD REPRESENTATIVE EXTENDED THE POST-VENTRICULAR ATRIAL REFRACTORY PERIOD (PVARP) IN ATTEMPT TO ELIMINATE THE PMT. THE PATIENT NOTED NO SYMPTOMS AND THE LEAD MEASUREMENTS WHERE WITHIN NORMAL LIMITS. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND IT WAS REPORTED THAT THE NOISE WOULD CONTINUE TO BE MONITORED. TWO MONTHS LATER, ADDITIONAL INFORMATION NOTED NOISE WAS AGAIN SEEN ON THE RV LEAD. THE NOISE WAS VERY FAST, BUT SHORT IN DURATION (3-5 SECONDS). THE PATIENT HAD AN X-RAY, WITH NO ISSUES OBSERVED. EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) EXPOSURE WAS DENIED BY THE PATIENT. PACING IMPEDANCE MEASUREMENTS WERE NOTED TO BE WITHIN NORMAL LIMITS. THE PATIENT WAS SCHEDULED TO COME TO THE CLINIC FOR FURTHER EVALUATION. IT WAS REPORTED THAT NOISE WAS SEEN WITH THE PATIENT'S PREVIOUS DEVICE HOWEVER A HEADER ISSUE WAS ALLEGED AT THAT TIME AND THAT DEVICE WAS REPLACED (MET PERFORMANCE SPECIFICATION). IT WAS NOTED THAT THE NOISE APPEARS TO OCCUR AT APPROXIMATELY THE SAME TIME OF DAY, AN EXTERNAL SOURCE WAS SUSPECTED. THE DEVICE WAS RETURNED FOR ANALYSIS. FOUR MONTHS LATER, DUE TO CONTINUED NOISE, OVERSENSING AND AN INAPPROPRIATE SHOCK, THE PHYSICIAN SUSPECTED A DEVICE HEADER ISSUE. A DEVICE REPLACEMENT WAS SCHEDULED. DURING THE REPLACEMENT, THE PHYSICIAN ATTEMPTED TO REPRODUCE THE NOISE BY MANIPULATING THE CHRONIC DEVICE HOWEVER WAS NOT ABLE TO REPRODUCE ANY NOISE IN THE POCKET OR WHEN PLACED IN STERILE WATER AND MANIPULATED. A KINK WAS NOTED IN THE LV LEAD ALONG WITH BLOOD IN THE LEAD. THE LV LEAD WAS REPAIRED AND A NEW COMPETITOR DEVICE WAS IMPLANTED (THE LV LEAD ISSUE WAS NOT SUSPECTED AS A CAUSE OF THE RV NOISE). NO NOISE WAS OBSERVED WITH THE NEW DEVICE CONNECTED TO THE CHRONIC LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19784 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0184| H220| 4549| N119| 4469| 4136| 4470| H170