BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1951494 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23030
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    May 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN SUSPECTED THE PNEMOTHORAX WAS DUE TO A PATIENT CONDITION, AND SUGGESTED IT MAY HAVE BEEN THE REASON FOR THE UNSUCCESSFUL INDUCTION TEST. NO INTERVENTION WAS PERFORMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A PROCEDURE TO IMPLANT THIS DEVICE, THE PATIENT'S SUBCLAVIAN VEIN WAS DISSECTED. THE DEVICE WAS IMPLANTED, AND DEFIBRILLATION TESTING WAS PERFORMED. A 21 J SHOCK WAS SUCCESSFUL, HOWEVER, NEITHER A 21 J NOR A 31 J SHOCK WAS SUCCESSFUL DURING A SECOND INDUCTION TEST, AND AN EXTERNAL SHOCK WAS APPLIED. NO FURTHER TESTING WAS PERFORMED. DURING A PRE-DISCHARGE FOLLOW-UP, A SMALL PNEUMOTHORAX WAS NOTED ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other