BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3936130 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13793
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE OF 1,700 TO 1,800 OHMS. THE PATIENT RECENTLY UNDERWENT A DEVICE REPLACEMENT AND HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE (PLI) WAS LATER DETECTED. DUE TO THE RECENT CHANGE OUT, A CONNECTION ISSUE WAS SUSPECTED AND THEY HAVE ELECTED TO MONITOR THE PATIENT FOR NOW. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412101 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 1851| E163| T125| T165| 1388T| 0145