BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2780479 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12813
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION NOTED BODY FLUID CONTAMINATION IN THE LEAD BARREL. THERE WAS A HOLE IN THE RV- SEAL PLUG. A REVIEW OF THE DEVICE MEMORY NOTED ONE LEAD LEAKAGE IN SESSION FAULT CODE. REVIEW OF THE STORED ELECTROGRAMS NOTED ARTIFACT THAT WAS CONSISTENT WITH BUBBLES ESCAPING FROM THE HOLE IN THE SEAL PLUG. LABORATORY ANALYSIS CONFIRMED THAT THE CAUSE OF THE NOISE NOTED AT IMPLANT WAS BUBBLES ESCAPING THROUGH A HOLE IN THE SEAL PLUG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPT TO IMPLANT THIS DEVICE, NOISE WAS PRESENT ON THE RIGHT VENTRICULAR (RV) CHANNEL. THIS NOISE WAS OVERSENSED AND WAS ABLE TO BE REPRODUCED WITH MANIPULATION OF THE DEVICE HEADER. THE DEVICE WAS REMOVED AND THE RV LEAD WAS TESTED THROUGH THE PACING SYSTEMS ANALYZER (PSA). THERE WAS NO NOISE PRESENT WHEN TESTED THROUGH THE PSA. A NEW DEVICE WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE IS TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1