BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042478 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01749
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE AS THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) INHIBITED RIGHT VENTRICULAR (RV) PACING DURING A ROUTINE IMPLANT PROCEDURE. THE RV LEAD HAD BEEN IMPLANTED AND WAS PACING SUFFICIENTLY. THE LEFT VENTRICULAR (LV) LEAD WAS THEN IMPLANTED AND CONNECTED TO THE DEVICE, AT WHICH POINT, THE RV LEAD CEASED PACING. THE LOCAL FIELD REPRESENTATIVE (FR) INDICATED THAT THE RV LEAD WAS DISCONNECTED, THE TERMINAL PINS WERE CLEANED AND THEN RE-INSERTED. THE DEVICE AND LEAD THEN BEGAN PACING AS DESIRED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening 4472| 0158| N119| MISMATCH| H177| (B)(4)| (B)(4)| 4543| 1283