BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053277 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03888
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    December 22, 2009
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD DEVELOPED ENDOCARDITIS DUE TO AN MILD INFECTION. THE PATIENT'S MEDICATION WAS CHANGED WHICH RESOLVED BOTH THE INFECTION AND INFLAMMATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 4542| 4193| 0181| H240| 4591| 4096