BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 2911508 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16260
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED IN THE EMERGENCY ROOM DUE TO SYNCOPE. THE FIELD REPRESENTATIVE SENT ELECTROGRAM (EGM) STRIPS FOR BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO REVIEW. TS OBSERVED OVERSENSING AND BELIEVES THE ISSUE TO BE SENSING OF INTRINSIC ACTIVITY BASED ON THE LEAD CONFIGURATION AND DEVICE SENSITIVITY. THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD ARE CURRENTLY CONNECTED TO A Y-ADAPTER THAT IS CONNECTED INTO THE RV PORT OF THE DEVICE, WHICH IS CONSIDERED OFF LABEL USE. PROGRAMMING OPTIMIZATION SUGGESTIONS FROM TS WILL BE DISCUSSED WITH THE PHYSICIAN. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18751 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R K063| 1297| 4053| 4054| 4513