BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 2780201 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12169
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THIS PATIENT'S PACEMAKER DETECTED INTERMITTENT LOSS OF CAPTURE ON A NON-BOSTON SCIENTIFIC RV LEAD. AN X-RAY NOTED THAT THE TERMINAL PIN MAY NOT HAVE BEEN ALL THE WAY INTO THE HEADER. MEASUREMENTS THROUGH THE PACING SYSTEM ANALYZER WERE NORMAL. HOWEVER, WHEN THE LEAD WAS RECONNECTED TO THE PACEMAKER A LOSS OF CAPTURE WAS NOTED AGAIN. THE PHYSICIAN ELECTED TO REPLACE THE PACEMAKER, HOWEVER, AFTER THE NEW PACEMAKER (K063) WAS IMPLANTED INTERMITTENT CAPTURE WAS STILL NOTED. THEREFORE THE NON-BOSTON SCIENTIFIC LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN HAS THOUGHT THE ISSUE COULD HAVE BEEN RELATED TO A MICRODISLODGEMENT OR A CARDIAC TISSUE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE NEW DEVICE (K063) REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4136| 4524| 7084| 1280| MISMATCH| K063| 1290| S606