BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2910074 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15399
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS DEVICE WAS PROGRAMMED OUT OF STORAGE MODE. THE CHRONIC LEADS WERE RECONNECTED TO THIS DEVICE. THE SET SCREWS WERE SECURED WITH THE PROVIDED TORQUE WRENCH. IT WAS NOTED THERE WAS NO VENTRICULAR PACING. REPROGRAMMING AND DIFFERENT LEAD CONFIGURATIONS VERIFIED THIS ISSUE. THE SET SCREWS AND LOOSENED AND THE CONNECTIONS WERE VERIFIED, HOWEVER NOISE, INTERMITTENT RV OVERSENSING WAS STILL OBSERVED. PERIODS OF NO PACING WERE OBSERVED DURING THE PROCEDURE AND THERE WAS ASYSTOLE. THERE WAS CONCERN THAT THERE WAS A DEVICE ISSUE. ONE FURTHER ATTEMPT TO DETERMINE THE ISSUE WAS MADE BY LOOSENING THE SET SCREWS AND INSERTING THE TORQUE WRENCH TO ALLOW AIR TO ESCAPE. AFTER THIS WAS PERFORMED, THE LEAD WERE RECONNECTED. APPROPRIATE SENSING AND PACING WERE OBSERVED IN ALL CHANNELS. IT WAS THOUGHT THE ISSUE WAS DUE TO AIR IN THE RIGHT VENTRICULAR PORT. IT COULD NOT BE CONFIRMED WHETHER THIS STEP TO REMOVE THE AIR HAD BEEN PERFORMED PRIOR TO THE LEAD INSERTION. POST PROCEDURE AND ONE DAY POST OPERATIVE FOLLOW UP REVEALED NO FURTHER ISSUES. IT WAS THOUGHT THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18916 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N165

    Patients

    Seq Age Sex Outcome Treatment
    1