BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 4140116 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17373
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    May 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEAD SAFETY SWITCH WAS TRIPPED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. REVIEW OF THE MEASUREMENTS REVEALED AN ACUTE DECREASE IN MEASUREMENTS FROM 530 OHMS TO 180 OHMS STARTING FIVE MONTHS EARLIER. IT WAS NOTED THAT THE IMPEDANCE MEASUREMENT HAS CONTINUED TO BE OUT OF RANGE SINCE THE FIRST DECREASE AND HAS AVERAGED 160-170 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED TROUBLESHOOTING OPTIONS, INCLUDING OBTAINING AN X-RAY TO EVALUATE SYSTEM INTEGRITY, AND PROGRAMMING OPTIONS. THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. THE SYSTEM CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620859 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4136| S603| 4137