BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946149 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20343
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHECK, PACE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WERE OBSERVED TO BE GREATER THAN 3,000 OHMS WITH NO CAPTURE. THE PHYSICIAN CHOSE TO CONTINUE TO MONITOR THIS OBSERVATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR H210| 4087| 4046| 0184| 4543