BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3905611 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11773
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCES GREATER THAN 2,000 OHMS AT FOLLOW UP. LV THERAPY WAS PROGRAMMED OFF UNTIL A REVISION PROCEDURE TOOK PLACE THE FOLLOWING DAY WHEREIN THE LV LEAD WAS SURGICALLY ABANDONED AND REPLACED IN ADDITION TO THE DEVICE BEING UPGRADED TO A QUADRIPOLAR SYSTEM. THE CAUSE OF THE OUT OF RANGE IMPEDANCES WAS NOT DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD AND CRT-D ARE NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383949 COGNIS IMPLANTABLE CHF PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0296| 4543| 4095| P108