BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151689 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06068
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS TRANSVENOUS DEFIBRILLATION LEAD, DURING THE POST-OP CHECK, SENSING WAS POOR AND THERE WAS NO CAPTURE AT HIGH OUTPUT. A CHEST X-RAY WAS OBTAINED WHICH REVEALED A POSSIBLE MICRO-DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD. IT WAS NOTED THAT THE PATIENT HAS SEVERE TRICUSPID REGURGITATION. 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 Required Intervention