BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3904522 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10442
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REMAINS IMPLANTED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN LOST TO FOLLOW UP FOR OVER TWO YEARS. THE PATIENT PRESENTED WITH SYNCOPE AND A VERY SLOW UNDERLYING RHYTHM. SYSTEM EVALUATION NOTED LOSS OF CAPTURE, VARYING PACING IMPEDANCE MEASUREMENTS WITH SOME OUT OF RANGE MEASUREMENTS THAT WERE LESS THAN 200 OHMS. ADDITIONALLY, THERE WAS NOISE WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION AND GREATER THAN TWO SECONDS OF ASYSTOLE FOR THIS PATIENT. THE PHYSICIAN SUSPECTED PROBABLE INSULATION DAMAGE TO THE RIGHT VENTRICULAR (RV) DEXTRUS LEAD. THE DEVICE WAS PROGRAMMED TO DOO MODE AND THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE. THE FOLLOWING DAY, THE RV LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384061 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 4137| S606| 4136