BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 1871673 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18988
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT ORIGINALLY HAD A BI VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND WAS DOWNGRADED TO A BI VENTRICULAR PACEMAKER. WHEN THE PACEMAKER WAS IMPLANTED THE NON-BOSTON SCIENTIFIC MANUFACTURED LEFT VENTRICULAR (LV) AND NON-BOSTON SCIENTIFIC MANUFACTURED RIGHT VENTRICULAR (RV) LEADS WERE USED IN AN OFF-LABEL MANNER. THE LV LEAD WAS IMPLANTED IN THE RV PORT AND THE RV LEAD WAS IMPLANTED IN THE LV PORT. THE NON-BOSTON SCIENTIFIC MANUFACTURED LV LEAD WAS PROGRAMMED TO UNIPOLAR PACING CONFIGURATION AND WAS NOTED TO BE OVERSENSING. THE OVERSENSING LED TO GREATER THAN TWO SECONDS OF ASYSTOLE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE REPROGRAMMED THE SENSITIVITY TO 10MV, WHICH HAS RESOLVED THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H120

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR H177| 4469| 6949| 4525| 4193| H120