BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223466 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10721
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DISSECTED RIGHT VENTRICULAR (RV) LEAD WAS FOUND DURING A POST PROCEDURAL FOLLOW-UP. THE PATIENT REFERRED NO SYMPTOMS AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. A SURGICAL LEAD REVISION TO REPOSITION THE LEAD WILL BE SCHEDULED. THIS LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT A SURGICAL LEAD REVISION WHICH SUCCESSFULLY REPOSITIONED THE LEAD. THE PATIENT WAS STABLE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324504 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI PLANT - ST. PAUL 0695

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R