BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873849 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17672
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THIS PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXHIBITING NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, WHICH WAS RESULTING IN INTERMITTENT INHIBITION OF PACING ASSOCIATED WITH ASYSTOLE. THE PHYSICIAN PLANS TO ABANDON THE LEAD AND THE CRT-D AND PLACE A NEW SYSTEM ON THE RIGHT SIDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT IS NEXT ON THE LIST FOR A HEART TRANSPLANT THEREFORE, NO SURGICAL INTERVENTION WILL BE PERFORMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0174| 0184| H177| H179| 4544| 4592| 4525| 1860| 1790| 1762| 0157| 0125