BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052832 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03725
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIXATION TOOL WHICH WAS USED DURING THE IMPLANT PROCEDURE WAS RETURNED AND ANALYZED. ANALYSIS FOUND NO CHARACTERISTICS OF THE TOOL THAT COULD HAVE CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THE LEAD REMAINS IMPLANTED. 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, DURING AN IMPLANT PROCEDURE, DIFFICULTY WAS ENCOUNTERED EXTENDING THE HELIX OF THIS RIGHT VENTRICULAR (RV) LEAD. THE CONNECTOR TOOL WAS RESEATED ON THE TOOL, AND A SECOND ATTEMPT TO EXTEND THE HELIX WAS UNSUCCESSFUL. THE TOOL WAS AGAIN REMOVED FROM THE LEAD, AND THE HELIX QUICKLY EXTENDED FULLY. DUE TO POOR THRESHOLDS, THE LEAD WAS REPOSITIONED, AND THE PATIENT REPORTED PAIN. AN ECHOCARDIOGRAM NOTED CARDIAC TAMPONADE, REQUIRING DRAINING OF THE PERICARDIUM. IT WAS ALLEGED THE LEAD PERFORATED THE PATIENT'S HEART DUE TO THE QUICK EXTENSION OF THE HELIX. THE PATIENT WAS HOSPITALIZED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R