BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946164 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20117
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE FURTHER UPDATED IF THE LEAD IS RETURNED FOR LABORATORY ANAYSIS POST COMPLETE EXPLANT. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS PARTIALLY EXPLANTED DUE TO SYSTEM EROSION. THE LEAD WILL BE FULLY EXTRACTED AT A LATER DATE AND WAS SURGICALLY CAPPED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 0185| E102