BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3043155 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03837
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP UPON DEVICE EVALUATION, THE LEAD SAFETY SWITCH (LSS) WAS TRIGGERED THAT OCCURED BACK IN (B)(6). HEALTH CARE PROFESSIONAL (HCP) DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THAT THE RIGHT ATRIAL (RA) LEAD HAD EXHIBITED AN OUT OF PACING IMPEDANCE MEASUREMENT THAT WOULD CAUSE THE LSS TO BE ACTIVATED. PATIENT WAS CURRENTLY IN ATRIAL FIBRILATION AT THE TIME WHEN ISOMETRICS WERE PERFORMED, UNABLE TO DETERMINE IF THERE WAS RESULTING NOISE. CURRENT IMPEDANCE MEASUREMENTS DISPLAYED WERE 480 OHMS. NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144726 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 4471| 1297| S606| 4470