BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4140451 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17279
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 13, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECORDS INDICATE THIS SYSTEM REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PRESENTED IN THE HOSPITAL DUE TO DIAPHRAGMATIC STIMULATION. UPON CHECK, IT WAS DETERMINED THAT A SAFETY SWITCH HAS BEEN TRIGGERED FOR THIS LEFT VENTRICULAR (LV) LEAD AND ANOTHER MANUFACTURER'S RIGHT ATRIAL (RA) LEAD DUE TO PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. THE FIELD REPRESENTATIVE PROGRAMMED LV LEAD FROM LV TIP TO DEVICE AND NO STIMULATION HAS BEEN OBSERVED THEREAFTER. FURTHERMORE, IT WAS NOTED THAT THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION (AF). THE ATRIAL LEAD WAS LEFT IN A UNIPOLAR CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618781 INGENIO IMPLANTABLE PULSE GENERATOR DTB GUIDANT CRM CLONMEL IRELAND V272

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR MISMATCH| 4068| 4024| 1297| 4513| V272| 4518| H125