BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042479 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01220
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. WHEN THE POCKET WAS OPENED, VISUAL INSPECTION REVEALED ONE OF THE DEVICE SETSCREWS HAD NOT BEEN TIGHTENED AND THIS LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND ACCEPTABLE MEASUREMENTS WERE OBTAINED POST REVISION. THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED THREE INAPPROPRIATE SHOCKS WITHIN TWO DAYS OF IMPLANT. INTERROGATION REVEALED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. IN ADDITION INCREASED THRESHOLD AND LOW SENSING MEASUREMENTS WERE REVEALED. A LEAD REVISION IS INTENDED. 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 0175

    Patients

    Seq Age Sex Outcome Treatment
    1