BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2171494 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09936
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTEMPTED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC, THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE; THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS ATTEMPTED TO BE INSERTED INTO THE MIDDLE CARDIAC VEIN. AS THE LEAD WAS PULLED BACK, IT WAS NOTED TO BE VERY TIGHT. A GREAT DEAL OF FORCE WAS USED TO PULL THE LEAD BACK, THAT THE POCKET WAS PULLING. THE LEAD EVENTUALLY WAS PULLED OUT; HOWEVER, IT WAS NOTED THAT THE PROXIMAL COIL HAD COME APART FROM ALL OF THE FORCE APPLIED TO PULL THE LEAD OUT. A NEW LEAD WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE SUCCESSFULLY COMPLETED. THE ATTEMPTED LEAD WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. NO 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 Other