BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173104 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10749
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    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 IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. AT IMPLANT THE SHOCK IMPEDANCE WAS 80 OHMS, BUT SHORTLY AFTER WAS OUT OF RANGE. ALL OTHER MEASUREMENTS WERE STABLE AND WITHIN RANGE. A REVISION PROCEDURE WILL BE PERFORMED WITHIN THE NEAR FUTURE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. IT WAS NOTED THAT THE DISTAL COIL PIN WAS IN THE POSITIVE CONNECTION OF THE DEVICE HEADER, AND THE DF-1 PLUG OF THE PROXIMAL COIL WAS IN THE NEGATIVE CONNECTION OF THE DEVICE HEADER. AFTER THE CONNECTIONS WERE CORRECTED, THE SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1