BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041060 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00795
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    July 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PORTION OF THE LEAD THAT WAS CUT AND REMOVED WAS DISGARDED BY THE HOSPITAL STAFF AND WILL NOT BE RETURNED. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN ALERT WAS REPORTED SIX MONTHS LATER VIA REMOTE MONITORING THAT THIS RV LEAD STILL EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE MEASUREMENTS. THE LEAD WAS EVALUATED AND AT THE PHYSICIANS DISCRETION, THE LEAD WILL REMAINED IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DUE TO THE HIGH IMPEDANCE MEASUREMENTS, A LEAD REVISION WAS PERFORMED. THIS RV LEAD WAS CUT DISTAL TO THE YOKE AND WAS CAPPED AND SURGICALLY ABANDONED. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE REPORTED ON THIS RIGHT VENTRICULAR (RV). THE LEAD REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention E102| 0147| 1860