BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 1862127 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16775
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, IT WAS CONFIRMED ONE OF THE DEFIBRILLATION PORT SETSCREWS WAS LOOSE. ADDITIONALLY, IT WAS NOTED THE PROXIMAL AND DISTAL DEFIBRILLATION CONNECTIONS WERE SWITCHED IN THE HEADER. PROPER CONNECTIONS WERE REESTABLISHED, AND NO OUT OF RANGE MEASUREMENTS WERE REPORTED FOLLOWING THE REVISION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A FOLLOW-UP APPOINTMENT, THIS DEVICE HAD MEASURED A SHOCK IMPEDANCE GREATER THAN 125 OHMS. AN X-RAY AND PATIENT MANEUVERS WERE PERFORMED. IT WAS BELIEVED A DEFIBRILLATION PORT SETSCREW WAS LOOSE. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention