BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 2913273 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00609
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED WITH THE NEW DEVICE. THE EXPLANTED DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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 A HOLE IN THE RV - SEAL PLUG. ALL OTHER SEAL PLUGS WERE INTACT, AND ALL SETSCREWS MOVED FREELY. 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 THE RECORDED ELECTROGRAMS FROM THE PROCEDURE DATE SHOWED NOISE THAT WAS CONSISTENT WITH AIR BUBBLES ESCAPING FROM THE RV - SEAL PLUG. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION WHILE PREVENTING BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. ON OCCASION, WRENCH PENETRATION CAN DAMAGE A SEAL PLUG WHICH CAN LEAD TO ACCESSORY SENSING PATHWAYS AND POTENTIALLY RESULT IN OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE SUCCESSFULLY IMPLANTED. HOWEVER, WHEN THEY MOVED THE PATIENT FROM THE TABLE TO RECOVERY, THE PATIENT EXPERIENCED ASYSTOLE FOR GREATER THAN TWO SECONDS. ADDITIONALLY, THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS. STRIPS RAN DURING TROUBLESHOOTING SHOWED NOISE THAT MAY HAVE BEEN CONSISTENT WITH AIR BUBBLES; HOWEVER, IT WAS DIFFICULT TO DETERMINE THE CAUSE OF THE NOISE. IT WAS NOTED THAT THE RV PACING AND SHOCKING IMPEDANCE MEASUREMENTS WERE NORMAL. ELECTROMAGNETIC INTERFERENCE (EMI) WAS NOT SUSPECTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED AIR BUBBLES WERE POSSIBLE, BUT THEY COULD NOT RULE OUT A POTENTIAL LEAD OR CONNECTION ISSUE, OR EMI. A DECISION WAS MADE TO REPLACE THE DEVICE. A NEW DEVICE WAS CONNECTED TO THE EXISTING LEADS. THE ELECTROGRAMS (EGMS) WERE ALL CLEAR, WITH NO NOISE PRESENT. THE CLINICIAN THEN NOTED THAT THE SHOCK IMPEDANCE READING WAS GREATER THAN 125 OHMS WHILE THE PHYSICIAN WAS CLOSING THE POCKET. BRIEF TROUBLESHOOTING REVEALED THE DF-1 TERMINAL PIN AND THE PORT PLUG HAD BEEN SWITCHED IN THE DEVICE HEADER. THESE WERE CORRECTED AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. THERE WERE NO FURTHER ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20722 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N163

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R