BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052559 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03684
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE COMPLETE LEAD WAS RETURNED. NO SIGN OF SETSCREW MARKS WAS NOTED ON THE TERMINAL PIN. THE LEAD PASSED ALL ELECTRICAL TESTING AND WAS CONTINUOUS. LABORATORY ANALYSIS COULD NOT CONFIRM THE FIELD ALLEGATIONS, THE LEAD MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE HIGH OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THIS RIGHT VENTRICULAR LEAD. IT WAS NOT POSSIBLE TO PACE OR SENSE WITH THIS RIGHT VENTRICULAR LEAD. THE PACING SYSTEM ANALYZER WAS CHANGED BUT THE PROBLEM PERSISTED. A NEW LEAD WAS USED WITH NORMAL MEASUREMENTS. THIS RIGHT VENTRICULAR LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156458 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1