BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173207 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10461
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME. THIS LEAD REMAINS IMPLANTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REINSERTED INTO THE LEAD BARREL AND REMAINS IN SERVICE. 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 A SCHEDULED ECHO PROCEDURE, INTERROGATION OF THIS RIGHT VENTRICULAR LEAD REVEALED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND NOISE ON THE ELECTROGRAM. THE DEVICE WAS REPROGRAMMED AND A REVISION PROCEDURE IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. WHEN THE POCKET WAS OPENED, VISUAL INSPECTION REVEALED THE LEAD HAD NOT BEEN INSERTED FULLY INTO THE LEAD BARREL. THE LEAD WAS ABLE TO BE REMOVED WITHOUT TURNING THE SETSCREW. THE LEAD WAS REINSERTED AND IT WAS THOUGHT THE ISSUE WAS RESOLVED.

    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 Required Intervention