BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781015 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13115
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED 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 REVEALED SENSING ISSUES. AN RV LEAD FRACTURE WAS SUSPECTED AND A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION THE PHYSICIAN NOTED REMOVAL DIFFICULTIES OF THIS LEAD WHICH PROLONGED THE PROCEDURE AND DAMAGED THE LEAD. THE EXTENDED PROCEDURE CAUSED THE PATIENT TO BE AT HIGH RISK OF INFECTION; THEREFORE THE COMPETITOR RIGHT ATRIAL (RA) LEAD AND DEVICE WERE REMOVED WITH THE RV LEAD. NO ALLEGATIONS WERE MADE AGAINST THE DEVICE OR RA LEAD. THE PRODUCTS WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS THEY WERE DISCARDED AT THE HOSPITAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0161

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R