BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771426 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12532
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    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 AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISLODGEMENT WAS DUE TO TWIDDLERS SYNDROME AND THE LEAD WAS EXTREMELY TWISTED AT THE HEADER. THIS RV LEAD WAS REPOSITIONED SUCCESSFULLY AND CURRENTLY REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED DISLODGED BY X-RAY DURING A SUBSEQUENT EPICARDIAL LEAD IMPLANT PROCEDURE. SENSING HAD DECREASED AND LOSS OF CAPTURE WAS OBSERVED AS A RESULT. A REPOSITION PROCEDURE WILL BE ATTEMPTED IN THE FUTURE. CURRENTLY, THIS RV LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS 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 Other| R