BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213005 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09718
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CONNECTED TO THE NEWLY RIGHT VENTRICULAR (RV) LEAD IMPLANTED LEAD. THE DEVICE WAS INTERROGATED AND REVEALED NORMAL MEASUREMENTS EXCEPT FOR SHOCKING IMPEDANCES RELATED TO THE CAN AS SHOCK IMPEDANCES WERE LESS THAN 20 OHMS. THE PHYSICIAN PRESSED DOWN ON THE POCKET AND SHOCK IMPEDANCE MEASUREMENTS REMAINED LOW. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED AND ADVISED THAT THEY HAVE SEEN THIS TYPE OF DEVICE BEHAVIOR WITH SMALLER PATIENTS. DUE TO THE PATIENT'S LOW BLOOD PRESSURE AND PRE-EXISTING LUNG DISEASE THE PHYSICIAN ELECTED TO REMOVE AND REPLACE THE DEVICE TO COMPLETE THE PROCEDURE. THE NEW DEVICE WAS TESTED AND REVEALED THE SAME MEASUREMENTS. THE PHYSICIAN ACCEPTED THE MEASUREMENTS AND THE POCKET WAS CLOSED. THE PATIENT WAS FOLLOWED UP THE NEXT DAY AND ALL MEASUREMENTS REMAINED NORMAL AND WITH IN RANGE. THE DEVICE WAS RETURNED FOR ANALYSIS WHILE THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313354 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI PLANT - ST. PAUL 0695

    Patients

    Seq Age Sex Outcome Treatment
    1