BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771635 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-14555
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION INDICATES THAT THE RATE/SENSE PORTION OF THIS RV LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED AS A RESULT OF THE NOISE AND OUT-OF-RANGE PACE IMPEDANCE. A NEW RV LEAD WAS PLACED. THERE WAS NO EVIDENCE OF A DEVICE OR DEVICE TO LEAD CONNECTION ISSUE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN PACE IMPEDANCE MEASUREMENT THAT MOST RECENTLY EXCEEDED 2,000 OHMS. THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT RECOMMENDED DOING POCKET MANIPULATION WHILE TAKING IMPEDANCE TESTS TO SEE IF ANY VARIABILITY IN IMPEDANCES COULD BE INVOKED THAT COULD POINT TO A MARGINAL CONNECTION ISSUE. CURRENTLY, THERE IS NO EVIDENCE OF NOISE IN ANY OF THE STORED ELECTROCARDIOGRAMS (EGMS). THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    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 75 YR 1861| E110| 0158| 4473