BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2052165 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04657
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS ALSO EXPLANTED AND REPLACED. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION OF THE DEVICE CONFIRMED A LARGE ARC MARK ON THE BACK OF THE TITANIUM CASE. BOSTON SCIENTIFIC'S HISTORICAL TREND DATA INDICATES THAT THE CAUSE OF ARCING DAMAGE LIKE THAT SEEN WITH THIS DEVICE IS DUE TO AN EXTERNAL HIGH VOLTAGE SHORT. PER THE REPORTED CLINICAL OBSERVATIONS, THE RIGHT VENTRICULAR LEAD EXHIBITED INSULATION DAMAGE. THE LIKELY SOURCE OF THE EXTERNAL HIGH VOLTAGE WAS THIS DAMAGED LEAD. REVIEW OF THE STORED MEMORY CONFIRMED THAT THE DEVICE RECORDED A SHORTED LEAD FAULT ON (B)(6) 2011 AND TWO MORE SHORTED LEAD FAULTS ON (B)(6) 2011. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. TESTING REVEALED THE OUTPUT BRIDGE WAS DAMAGED. RIGHT AND LEFT VENTRICULAR AND ATRIAL PACING PULSES WERE VERIFIED AND RV AND LV PACING IMPEDANCE MEASUREMENTS WERE NORMAL DURING TESTING. DAILY MEASUREMENTS WERE REVIEWED AND IT WAS NOTED THAT LEFT VENTRICULAR PACING IMPEDANCE MEASUREMENTS INCREASED TO GREATER THAN 2,000 OHMS BEGINNING THE WEEK OF (B)(6) 2011 AND REMAINED HIGH UNTIL DEVICE EXPLANT. ADDITIONALLY, RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS THE WEEKS OF (B)(6) 2011 AND WERE THEN "N/R" UNTIL THE DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR UNDERWENT A PULMONARY ABLATION DUE TO ATRIAL FIBRILLATION. DURING THE PROCEDURE EXTERNAL DEFIBRILLATION WAS REQUIRED. THE PATCHES OF THE EXTERNAL DEFIBRILLATOR HAD BEEN ATTACHED ON THE LEFT AND RIGHT SIDES OF THE PATIENT'S CHEST. AFTER THE ABLATION PROCEDURE THE DEVICE WAS INTERROGATED AND HIGHER THAN BEFORE STIMULATIONS THRESHOLDS AND PACING IMPEDANCES ON THE RIGHT VENTRICULAR DEFIBRILLATION LEAD AND LEFT VENTRICULAR LEAD WERE FOUND. IN ADDITION, A LOW SHOCK IMPEDANCE MEASUREMENT WAS NOTED DUE TO AN ALERT MESSAGE OF LOW SHOCK IMPEDANCE LESS THAN 20 OHMS NOTIFICATION. THIS WAS LIKELY A RESULT OF THE COMMANDED 31J SHOCK REQUIRED DURING THE ABLATION PROCEDURE. THIS WAS A COMMANDED SHOCK FOR CARDIOVERSION TO TERMINATE ATRIAL FIBRILLATION. THE DEVICE WAS INTERROGATED; THE ATRIAL LEAD REVEALED NORMAL VALUES AND PARAMETERS. THE RIGHT VENTRICULAR SENSING WAS NORMAL, HOWEVER, HIGH PACING IMPEDANCE AND HIGH THRESHOLDS WERE NOTED. THE SHOCK IMPEDANCE WAS NORMAL DURING INTERROGATION. THE LEFT VENTRICULAR IMPEDANCE WAS GREATER THAN 2,000 OHMS, AND THRESHOLDS WERE HIGH. ALL OTHER MEASUREMENTS WERE NORMAL. A REVISION PROCEDURE WAS PERFORMED; UPON REMOVAL OF THE DEVICE, A BLACK MARK WAS NOTED ON THE DEVICE. THE RIGHT VENTRICULAR LEAD HAD BEEN LYING ON THE BLACK MARK OF THE DEVICE AND THE LEAD INSULATION WAS DAMAGED. A SHORTED LEAD CONDITION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H240

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R