BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1861062 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15235
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCES. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    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 72 YR 4471| 0185| T135