BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952676 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23485
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE, THE INITIAL CONTACT OF THIS RIGHT VENTRICULAR (RV) LEAD WAS WITH THE RV MYOCARDIUM. THIS RESULTED IN A VENTRICULAR TACHYCARDIA EPISODE TO OCCUR AT 160 BEATS/MINUTE. EXTERNAL DEFIBRILLATION OF 360 JOULES WAS ADMINISTERED, WHICH BROUGHT THE PATIENT BACK TO SINUS RHYTHM. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1