BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905406 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12073
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    July 11, 2011
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BOSTON SCIENTIFIC REPRESENTATIVE PERFORMED A SYSTEM CHECK AFTER THE MOST RECENT RED ALERT WAS RECEIVED. THERE WERE NO OUTSTANDING DEVICE ISSUES AND NO ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED AND 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 SYSTEM HAD BEEN EXHIBITING HIGH SHOCKING IMPEDANCE MEASUREMENTS AND ELEVATED THRESHOLD MEASUREMENTS. PACING IMPEDANCE AND INTRINSIC AMPLITUDE MEASUREMENTS HAVE BEEN STABLE. SUBSEQUENT INFORMATION WAS RECEIVED CONFIRMING THAT A LATITUDE RED ALERT HAD BEEN GENERATED DUE TO OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ALL OTHER MEASUREMENTS ARE STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383456 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0186

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR E102| 0186| T177