BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162566 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07074
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL NOT BE RETURNED FOR ANALYSIS AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE END OF A DEVICE REPLACEMENT PROCEDURE OUT OF RANGE SHOCKING IMPEDANCES WERE NOTED WHEN CONNECTING THE NEW DEVICE TO THE EXISTING RIGHT VENTRICULAR (RV) LEAD. SHOCKING IMPEDANCES WERE MEASURED WITH A PACING SYSTEM ANALYZER (PSA) WHICH SHOWED OUT OF RANGE IMPEDANCES OF THE PROXIMAL COIL. THE DEVICE WAS RECONNECTED TO THE LEAD EXCLUDING THE PROXIMAL COIL. THE SHOCKING IMPEDANCES THEN APPEARED TO BE WITHIN NORMAL RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE PROCEDURE.

    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