BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170302 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10199
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS RIGHT VENTRICULAR (RV) LEAD SENSED ATRIAL ACTIVITY BECAUSE A PORTION OF THE DISTAL COIL WAS PROTRUDING THROUGH THE TRICUSPID VALVE. THE SUSPECTED CAUSE WAS THAT THE RV LEAD TIP HAD BEEN IMPLANTED CLOSE TO THE TRICUSPID VALVE. THE PATIENT WAS NOT PACER-DEPENDENT, THERE WAS NO INHIBITION OF PACING OR ASYSTOLE LONGER THAN TWO SECONDS. THE ISSUE COULD NOT BE RESOLVED BY REPROGRAMMING, AND IT WAS NOTED THAT THE LEAD WOULD HAVE TO BE REPOSITIONED TO RESOLVE THIS ISSUE. THE PHYSICIAN CHOSE TO MONITOR THE PATIENT AT THIS TIME. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1