BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6730047 · Received July 20, 2017

    Report

    Report Number
    2124215-2017-12739
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073/S041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. TWO SEGMENTS OF THE LEAD WERE RETURNED; SOME PORTION OF THE LEAD MAY HAVE BEEN MISSING. LASER EXTRACTION DAMAGE WAS NOTED ON THE INSULATION. BLOOD/BODY FLUID WAS NOTED IN THE LUMEN. MICROSCOPIC INSPECTION NOTED THAT THE TRILUMEN INSULATION HAD WEBBING DAMAGE APPROXIMATELY 277-275 MILLIMETERS FROM THE TIP. DUE TO THE LOCATION AND TYPE OF DAMAGE IT IS LIKELY THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION. THERE WAS ALSO A TRILUMEN INSULATION ABRASION NOTED THROUGH TO THE DISTAL HIGH VOLTAGE LUMEN APPROXIMATELY 130-146 MILLIMETERS FROM THE TIP. THE ABRASION WAS A LONG, SMOOTH ABRASION. DUE TO THE LOCATION AND TYPE OF DAMAGE IT WAS LIKELY CAUSED BY LEAD-ON-LEAD INTERACTION WITHIN THE HEART.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND THE ASSOCIATED RIGHT ATRIAL (RA) LEAD DISPLAYED NOISE THAT WAS REPORTED TO HAVE BEEN PRESENT FOR AWHILE. THE DEVICE HAD BEEN PROGRAMMED VVI IN RELATION TO THE RA NOISE. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED STEADILY INCREASING IMPEDANCES. CONCERN OVER A LEAD FRACTURE WAS PRESENT. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE DEVICE, RA LEAD AND RV LEAD WERE EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510177 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R 0174| 0292| 4086| 7740| D142| E110| T125