BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2173616 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10793
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    August 2, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    THE RV LEAD AND DEVICE REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMEDED REPORT SUBMITED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A REVIEW OF DEVICE MEMORY SHOWED THE LAST DELIVERED SHOCK PRODUCED A SHOCK IMPEDANCE OF 28 OHMS. THE DEVICE MEETS SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, AND SUB-Q ARRAY LEAD REPORTED HEARING BEEPING TONES COMING FROM THE DEVICE EVERY SIX HOURS. THE BEEPING TONES WERE ALSO IDENTIFIED DURING MAGNET APPLICATION BY THE PATIENT. A DATA DISK WAS SENT INTO A BOSTON SCIENTIFIC ENGINEER FOR REVIEW. AFTER REVIEW, THE ENGINEER'S ANALYSIS CONFIRMED LOW SHOCKING IMPEDANCE VALUES OF LESS THAN 20 OHMS. THE REASON FOR THE BEEPING TONES WAS LIKLEY DUE TO A SHORTED LEAD CONDITION WHICH COULD LEAD TO INTERNAL CIRCUITRY DAMAGE TO THE DEVICE AND THUS PREVENT THE DEVICE FROM EFFECTIVELY DELIVERING SHOCK THERAPY. NO ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD AND DEVICE REMAIN IMPLANTED.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION OF THIS PRODUCT ISSUE REVEALED THAT DURING THE DEVICE TESTING WITH THE PATIENT IN (B)(6) 2011, ELECTROGRAM ANALYSIS WAS PERFORMED WHILE THE PATIENT WAS PERFORMING A PALM PRESS AND MOVEMENTS WITH SHOULDERS AND ARMS; NOISE WAS PRESENT DURING THE MOVEMENTS ON THE SHOCK CHANNEL ONLY, THE RIGHT VENTRICULAR PACE/SENSE CHANNEL WAS FREE OF NOISE. A CHEST X-RAY WAS PERFORMED TO EVALUATE THE LEAD COIL POSITION AND LEAD CONDITION. THE X-RAY REVEALED THAT ONE OF THE THREE FINGERS OF THE SQ ARRAY WAS DAMAGED WHICH WAS SUSPECTED TO BE CAUSE FOR THE LOW SHOCK IMPEDANCE. AS THE DAMAGE OF THE SQ ARRAY WAS LOCATED ON THE METALLIC PORTION OF THE FINGER, IT DID NOT AFFECT THE SQ ARRAY FUNCTION. A REVISION PROCEDURE WAS PERFORMED AND A NEW DEVICE WAS IMPLANTED WITH THE POSSIBILITY TO REPROGRAM THE SHOCK VECTOR AND TO HAVE A HIGHER SHOCK IMPEDANCE. A HORIZONTAL SQ CONFIGURATION WAS SELECTED AS THIS MADE FOR A BETTER SHOCKING FIELD OVER THE HEART. THE DAMAGE TO THE SQ ARRAY WAS REPAIRED WITH A LEAD REPAIR KIT. NO DAMAGE TO THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS CONFIRMED AND THE LEAD REMAINED IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY 5 MONTHS LATER, THE DECISION WAS MADE TO REMOVE AND REPLACE THE DEVICE DUE TO THE MANY SHOCKING VECTORS THAT COULD BE THE CAUSE FOR THE LOW SHOCK IMPEDANCE. WITH A NEW DEVICE IT WAS FELT THERE WOULD BE THE POSSIBILITY TO REPROGRAM THE SHOCK VECTOR AND TO HAVE A HIGHER SHOCK IMPEDANCE. THE DEVICE WAS REMOVED AND REPLACED AND A HORIZONTAL SQ CONFIGURATION WAS SELECTED AS THIS MADE FOR A BETTER SHOCKING FIELD OVER THE HEART (THE PROXIMAL COIL WAS A LITTLE OUTSIDE OF THE HEART) AND THE FACT THAT DURING PREPARATION OF THE ELECTRODES, THE INSULATION OF THE PROXIMAL SHOCK COIL WAS DAMAGED AND REPAIRED WITH A LEAD REPAIR KIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H249

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R