BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3904302 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09820
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    February 10, 2014
    Report Date
    April 7, 2014
    Manufacturer
    GUIDANT CRM 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. VISUAL INSPECTION CONFIRMED THE HEADER WAS LOOSE FROM THE DEVICE CASE. THE MEDICAL ADHESIVE (MA), USED TO AFFIX THE HEADER TO THE DEVICE CASE, REMAINED ON THE BOTTOM OF THE HEADER WITH MINIMAL MA ON THE CASE. AN X-RAY OF THE HEADER CONFIRMED THAT ALL FEEDTHRU WIRES ARE INTACT. 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. ANALYSIS CONCLUDED THAT THE LOOSE HEADER WAS NOT THE CAUSE OF THE LOW SENSING OR THE IMPEDANCE PROBLEM REPORTED BY THE FIELD. THE FEEDTHRU WIRES ARE INTACT AND THE DEVICE PASSED AUTOMATED SENSING AND IMPEDANCE MEASUREMENT TESTS. THERAPY REMAINED AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN INTENDED DEVICE REPLACEMENT PROCEDURE, VISUAL OBSERVATION OF THIS PACEMAKER REVEALED THE DEVICE HEADER WAS PARTIALLY LOOSENED FROM THE BATTERY PORTION OF THE DEVICE. THIS DEVICE WAS REPLACED. THERE WAS CONCERN THAT THIS MAY HAVE LED TO THE RIGHT VENTRICULAR LEAD SENSING AND DECREASED IMPEDANCE ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385034 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 4457| 1297| 4568