BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860463 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14987
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LEAD WAS SUCCESSFULLY IMPLANTED AND THIS LEAD HAS NOT BEEN RETURNED. SHOULD THIS LEAD BE RETURNED FOR ANALYSIS OR SHOULD MORE INFORMATION BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT APPROXIMATELY FOUR DAYS FOLLOWING IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE DISLODGEMENT WAS CONFIRMED VIA XRAY. A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LEAD, AND THE FORMER LEAD WAS EXPLANTED. IT WILL NOT BE RETURNED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0286

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R