BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE

    MDR report key: 7981288 · Received October 18, 2018

    Report

    Report Number
    2124215-2018-17219
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    April 15, 2018
    Report Date
    August 2, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    UDI-DI
    00802526559402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 LEFT VENTRICULAR (LV) PACING IMPEDANCE MEASUREMENTS. LV IMPEDANCE MEASUREMENTS BEGAN TRENDING UPWARDS SEVERAL MONTHS PRIOR AND RECENTLY WENT OUT OF RANGE AT LEAST TWO TIMES. NO OVERSENSING WAS NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS FOR LEAD SAFETY SWITCH. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817681 ACCOLADE IMPLANTABLE PULSE GENERATOR NKE GUIDANT CRM CLONMEL IRELAND U128 00802526559402

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR