BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852008 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14654
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED, IT WILL NOT BE RETURNED FOR ANALYSIS AND, AS SUCH, THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD OVERSENSED NOISE RESULTING IN PACING INHIBITION. THE PATIENT HAD AN UNDERLYING RHYTHM SO THERE WAS NO ASYSTOLE. ATTEMPTS TO RECREATE THE NOISE WERE SUCCESSFUL. A LEAD FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. DURING THE EXPLANT PROCEDURE THE HELIX MECHANISM BECAME STUCK AND WOULD NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention T180| 4470| 0184