BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2801825 · Received October 23, 2012

    Report

    Report Number
    2124215-2012-14279
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    July 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED SEVERED 118 MILLIMETERS (MM) FROM THE TERMINAL PIN IN TWO SEGMENTS. TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS LEAD WAS EXPLANTED DUE TO A POSSIBLE INFECTION. THE LEAD WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED INCREASE SHOCK IMPEDANCE MEASUREMENTS AND INCREASED PACING THRESHOLD MEASUREMENTS. ADDITIONALLY, R-WAVE MEASUREMENTS DECREASED ALONG WITH PACING IMPEDANCE MEASUREMENTS. A CHEST X-RAY WAS PERFORMED WHICH REVEALED THIS LEAD HAD PULLED BACK AND THE CAN WAS FLIPPED OVER. IT WAS SUSPECTED THE LEAD DISLODGED DUE TO TWIDDLER'S SYNDROME. A LEAD REVISION PROCEDURE WAS SCHEDULED FOR A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 0181| E102