BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950603 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23582
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD DEVELOPED MULTIPLE INFECTIONS AND HAD TO BE PULLED FROM THE DEVICE REPLACEMENT SCHEDULE AND WILL BE ON ANTIBIOTICS FOR SEVERAL WEEKS. IT WAS NOTED THAT A CHANGE OUT PROCEDURE NEEDED TO BE SCHEDULED; HOWEVER, DUE TO THE INFECTION THE PROCEDURE MAY BE SCHEDULE BEYOND THE RECOMMENDED TIMEFRAME. TECHNICAL SERVICES (TS) EXPLAINED THAT THIS WOULD BE OUTSIDE OF THE RECOMMENDED THREE MONTHS WINDOW FOR REPLACEMENT. TS COULD NOT PROVIDE ANY FURTHER LONGEVITY ESTIMATE OTHER THAN THE THREE MONTH WINDOW. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT A CHANGE OUT PROCEDURE HAS NOT BEEN SCHEDULED AT THIS TIME. THE SOURCE OF THE INFECTIONS IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention 0157| 4480| T125