BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3213000 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09946
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    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

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 APPROXIMATELY THREE MONTHS POST IMPLANT, THIS DEVICE WITH NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A LEAD REVISION WAS PERFORMED. AFTER THE DEVICE WAS EXPOSED, VISUAL OBSERVATION REVEALED THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE LEAD BARREL AND THE SET SCREW HAD NOT BEEN TIGHTENED. THE LEAD DISTAL CONNECTOR WAS PULLED BACK WITHOUT LOOSENING THE SET SCREW. THE LEAD WAS REINSERTED INTO THE DEVICE HEADER AND THE SET SCREW WAS SECURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312425 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F161

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R