BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852629 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14244
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    April 28, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD REMAINS IMPLANTED, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION 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 DISLODGED. THE RV RATE COUNT IS GREATER THAN 250 BEATS PER MINUTE, AND THE R-WAVE AMPLITUDE VALUES FLUCTUATED. IT WAS NOTED THAT OVERSENSING WAS NOT SEEN DURING PROVOCATIVE MANEUVERS AND POCKET MANIPULATION. AS A RESULT OF THE RV LEAD DISLODGEMENT, A SIGNIFICANT PORTION OF THE DISTAL SHOCKING COIL IS POSITIONED IN THE RIGHT ATRIUM (RA), AND THUS PICKING UP P-WAVES RESULTING IN DOUBLE COUNTING. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1