BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173841 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10809
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE TO OUR COMPANY, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS REPOSITIONED DUE TO LOSS OF CAPTURE AT 7.5V AT 2.0MS. IMPEDANCE MEASUREMENTS WERE ALSO TRENDING DOWNWARD SINCE IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED IN ADDITION TO THE LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R