BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3212932 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09665
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. HIGH POWERED VISUAL INSPECTION CONFIRMED THE HEADER WAS SEPARATED FROM THE DEVICE CASE. THE DEVICE WAS THEN 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. LOOSE/SEPARATED HEADERS ARE DUE TO AN INSUFFICIENT BOND STRENGTH BETWEEN THE HEADER AND THE DEVICE CASE.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE ELECTIVE DEVICE REPLACEMENT PROCEDURE IT WAS NOTED THAT THE DEVICE HEADER WAS NOT TIGHTLY ADHERED TO THE BODY OF THE DEVICE CAN. IT WAS ALSO DIFFICULT TO REMOVE THE ATRIAL LEAD FROM THE DEVICE HEADER AND EXTRA FORCE WAS USED TO EXTRACTED THE LEAD FROM THE DEVICE HEADER. THERE WERE NO ALLEGATION WHEN IT COMES TO THE DEVICE WHEN THE DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312193 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1