BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3951183 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14291
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED AND NOTED NO IRREGULARITIES IN LEAD BARREL AND SET SCREWS WERE FOUND TO MOVE NORMALLY. MECHANICAL AND ELECTRICAL TESTING WERE PERFORMED AND PASSED ALL MEASUREMENTS. HOWEVER, A HOLE WAS NOTED IN THE RIGHT VENTRICLE SEAL PLUG WHERE OVERSENSING IS CONSISTENT WITH AIR BUBBLES ESCAPING. THE DEVICE WAS CLINICALLY OUT OF SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACEMAKER WITH A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND BLOOD IN THE HEADER WAS NOTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE PACEMAKER WAS NEVER IN SERVICE AND THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428326 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR MISMATCH| K063| 1290