BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3904363 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10773
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 5, 2014
    Report Date
    June 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A HIGH POWER VISUAL INSPECTION OF THE DEVICE HEADER NOTED THE RIGHT VENTRICULAR (RV) TIP TERMINAL BLOCK WAS MISALIGNED IN THE RV LEAD BARREL. A LEAD TIP COULD NOT BE INSERTED INTO THE RV TIP TERMINAL BLOCK. FURTHER EXAMINATION FOUND THE LEAD HAD BEEN FULLY INSERTED AT ONE POINT. THE RV TIP TERMINAL BLOCK WAS REALIGNED AND THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. BASED ON STORED DEVICE DATA AND LABORATORY ANALYSIS, IT WAS CONCLUDED THE RV TERMINAL BLOCK WAS MISALIGNED DURING THE RV LEAD REVISION PROCEDURE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS. IT WAS FOUND THE LEAD HAD DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED AND THE LEAD WAS REPLACED. THE DEVICE WAS PLACED BACK IN THE POCKET AND INTERROGATION REVEALED HIGH PACING IMPEDANCE MEASUREMENTS. THE DEVICE WAS THEN SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383775 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R K173| 4137| 4136| 4135