BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE

    MDR report key: 7981180 · Received October 18, 2018

    Report

    Report Number
    2124215-2018-17221
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    March 15, 2018
    Report Date
    August 3, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    UDI-DI
    00802526559402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 A LEAD SAFETY SWITCH WAS TRIGGERED ON THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BY HIGH, OUT-OF-RANGE RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS. RV IMPEDANCE MEASUREMENTS BEGAN JUMPING UPWARDS SEVERAL MONTHS PRIOR AND RECENTLY WENT OUT OF RANGE. NO NOISE WAS NOTED AND HIGH IMPEDANCE MEASUREMENTS COULD NOT BE RECREATED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED REPROGRAMMING LEAD TO A SPLIT CONFIGURATION WITH UNIPOLAR SENSING. THE CALLER CONFIRMED THAT THEY WOULD MAKE THIS CHANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820892 ACCOLADE IMPLANTABLE PULSE GENERATOR NKE GUIDANT CRM CLONMEL IRELAND U128 00802526559402

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR