BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3212555 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09523
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT ISSUE WILL BE UPDATED WHEN DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION OF THE DEVICE REVEALED A HOLE IN THE RIGHT VENTRICULAR (RV) TIP SEAL PLUG. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, 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. PROPER SENSING WAS CONFIRMED IN THE LABORATORY, USING TESTS SPECIFICALLY DESIGNED TO VALIDATE SENSE AMPLIFIER OPERATION ALONG WITH ITS ASSOCIATED COMPONENTS. ALTHOUGH THE PRESENCE OF FLUID IN THE HEADER SELDOM CREATES A PERFORMANCE ISSUE, FLUID PENETRATION MAY CAUSE OVERSENSING. IN THIS CASE, THE HOLE IN THE RV SEAL PLUG LIKELY CONTRIBUTED TO THE REPORTED ISSUES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING IMPLANT OF THIS DEVICE, THE PATIENT RECEIVED A SHOCK WHILE BEING MOVED TO THE GURNEY. THE DEVICE WAS RE-INTERROGATED AND IT WAS DETERMINED THAT THE SHOCK WAS INAPPROPRIATE AND DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE POCKET WAS RE-OPENED TO CHECK THE CONNECTIONS AND WHEN THEY WERE RE-CLOSING THE POCKET, NOISE WAS SEEN AGAIN. THE PHYSICIAN TAPPED ON THE DEVICE HEADER AND REPRODUCED THE NOISE. THE PHYSICIAN ALSO NOTED INAPPROPRIATE PACING INTO A PREMATURE VENTRICULAR CONTRACTION (PVC) AND THERE WERE NOT AP MARKERS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312303 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L