BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 4131457 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14135
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    February 3, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS NOT CAPTURING AND AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS NOTED WITH NO SENSING. A LEAD FRACTURE WAS ALLEGED. THE PATIENT WAS NOT PACEMAKER DEPENDENT. THE TECHNICIAN REPROGRAMMED THE DEVICE TO AAI AND A FOLLOW UP WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    -

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT DURING THE REPLACEMENT OF THIS RIGHT VENTRICULAR LEAD A CLEAR FRACTURE OF THE LEAD WAS NOTED. THE DEVICE WAS INTERROGATED AND REVEALED THAT LOW OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THE RIGHT ATRIAL LEAD. UNDER FLUOROSCOPY A LEAD FRACTURE WAS CONFIRMED WHILE INSULATION DAMAGE WAS NOTED ON THE RIGHT ATRIAL COMPETITOR LEAD. THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED WHILE THE RIGHT ATRIAL LEAD AND THE DEVICE WERE EXPLANTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611799 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 4457| S606| 4136