BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053102 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04428
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD REMAINS IN SERVICE AND WILL NOT BE RETURNED FOR ANALYSIS. THEREFORE, THE CLINICAL OBSERVATIONS OBSERVED CAN NOT BE CONFIRMED. 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 DURING A ROUTINE FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS MEASUREMENTS AND A DECREASE IN PACING IMPEDANCES FROM 1100 OHMS TO 475 OHMS. AN RV LEAD DISLODGMENT WAS SUSPECTED AND THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE LEAD WAS CHECKED AND A LEAD DISLODGMENT WAS NOT CONFIRMED. A REVISION PROCEDURE WAS PERFORMED AND REVEALED THAT WHEN THE LEAD WAS DISCONNECTED FROM THE DEVICE SUTURES WERE EXTREMELY TIGHT AND WERE NOT PROPERLY INSERTED INTO THE SUTURE SLEEVES, BUT DIRECTLY IN CONTACT WITH THE INSULATION ON THE LEAD. THE PHYSICIAN INSPECTED THE LEAD AND VERIFIED THAT NO DAMAGE HAD OCCURRED. THE LEAD WAS REPOSITIONED, TESTED AND REVEALED GOOD MEASUREMENTS. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156897 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI PLANT - ST. PAUL 0693

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R