BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173619 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10933
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGICAL REVISION PROCEDURE OCCURRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID BECOME DISLODGED JUST A FEW DAYS AFTER IMPLANT. THERE HAD BEEN NO CAPTURE AT MAXIMUM OUTPUT INITIALLY NOTED IN THE ROUTINE PATIENT FOLLOW UP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention